Nothing but blue skies · Pharmacovigilance Risk management plans, DSURs, PSURs, developing and...

Experts In Drug Development, Regulatory Affairs, Quality Management And Pharmacovigilance

Nothing but blue skies

www.bluereg-group.com

Common issues and challenges• The pharmaceutical industry is governed by a complex

and evolving regulatory framework• Navigating and executing the best pathway requires

expertise and resources not always available within companies

The benefits of using BlueReg• Flexible approach and dynamic team with extensive

hands-on experience• Proven track record in a broad range of consulting and

operational activities

How we make it work• Evaluation of client’s specific needs and tailoring

consulting services accordingly• Provision of both advice and following through with

hands-on operational execution

Our activitiesDevelopment and regulatory strategyRegistration strategy, scientific support and positioning, regulatory requirements

Interactions with regulatory agenciesAssistance with seeking scientific advice (EMA or national), orphan drug designation, PIPs

Scientific writing and content adviceAll CTD modules, response to agency questions, agency briefing packages, IMPDs, clinical trial applications

RegistrationCentralised, decentralised and national submissions, eCTD publishing

PharmacovigilanceRisk management plans, DSURs, PSURs, developing and auditing PV systems and practices, PSMFs, case processing, in-house PV database

Due diligenceConduct regulatory and clinical evaluations

Legal representative for non-eu clientsBlueReg registered as small and medium sized-entreprise (SME) with the EMA

Development and registrationEarly-access programmes (ATU), assistance with ANSM meetings

Post-registration activitiesWriting and Advice on CMC and labelling variations (DMI)

Pharmaceutical companiesAssistance and advice with obtaining “Exploitant” status, audits, preparation of client-customized SOPs, provision of deputy QPs (PRI)

Advertising reviewPromotional material review, assistance for obtaining visas

Interaction with healthcare professionalsCompliance of the interaction with HCPs (DMOS), assistance in the certification of sales reps (Charte de la visite médicale)

BlueReg is a consultancy organization offering strategic advice and hands-on outsourcing solutions to life sciences companies through the entire lifecycle of their products. We provide flexible solutions or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.

Global Drug Development (EU/US)


Our services• Due diligence for licensing or investment decision making• Strategic expert input and regulatory advice (CMC, non-clinical, efficacy

& safety)• Data assessment, interpretation & positioning• Advice on global development plans (including Integration of value-

based payer evidence requirements), Global regulatory strategy and meetings with regulators or payers

• Scientific writing of regulatory documents (EU & US): Briefing documents for scientific Advice, Orphan Drug Designation (ODD), Paediatric Investigation Plan (PIP), IMPD and IND, Clinical study reports, MAA and NDA/BLA modules, Responses to Agency questions (RTQ)

• Scientific writing of Pharmacovigilance/safety documents: RMP, DSURs, PBRERs

• Operational support and Regulatory project management for ODD, PIP, scientific advice, IMPD, IND, CTAs, CSRs, DSURs… (including Regulatory publishing)

• Development of Client-Customised Operational Platforms

When work with us?The team can cover any step of the development process, providing consultancy or hands-on operational support.

Among our latest missions• Writing clinical modules for submission in EU and US• Subject Matter Expert for specific drug/indication• Supporting strategy and writing RTQ for centralized procedure• Coordination/leadership for EU and US development activities

within a ‘virtual’ company set-up

The teamA team of experienced consultants and scientific writers with significant experience in the pharmaceutical industry.

Our clientsFrom start-ups to global pharma companies with punctual, repetitive or permanent need for support.

Why work with us?Our team hold a flexible skill set ranging from development strategy to operational execution, as well as leading and managing projects.They can also work closely with other specialists in BlueReg to provide an integrated development and regulatory service.

Global Drug Development (EU/US)


Global Regulatory Registration Services


Our services• Regulatory advice on development and interactions with regulatory

agencies

• Clinical Trial Application (CTA)

• Scientific Advice (EMA or national agencies)

• Orphan Drug Designation (ODD)

• Paediatric Investigation Plan (PIP)

• Drug registration and registration strategy

• MAA dossier preparation: Data analyses, strategic input and scientific writing of all CTD sections

• Management of post approval commitments

• Post MAA regulatory maintenance: CMC, clinical & safety Variations

• Regulatory publishing (eCTD, NeeS)

• CMC compliance projects

• Platforms: Development of Specific (client or activities) supports platforms

When work with us?The team covers the whole development process as a consultant or operational support, from concept to approval, on a global or multi-national projects.

Among our latest missions• Full integration of our consultants within global project teams for

development projects (new indications, line extensions)

• Management of Centralised Procedure

• Provision of all module 1 documents including development of SmPC, risk management plan, environmental risk assessment

The teamA team of highly qualified consultants with significant hands-on industry experience including experts in Regulatory Affairs, CMC and publishing.


Why work with us?Our team hold a flexible skill set ranging from development strategy to operational execution, as well as leading and managing projects.They can provide expert advice followed by hands-on operational activities.

Global Regulatory Registration Services

As an outsourcing and consulting services company, BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide.BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world, supported by the expertise of our consultants and our international qualified partners.BlueReg will support your geographic registration roll out in ICH and non-ICH regions by providing you with advice and regulatory support on the various critical steps of your regulatory plans.We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs and biologicals.

Outsourcing Platform on Registration for Export Countries“OPREC”

CTD Core DossierGeographical roll outSubmission & follow up until approval


At a project management level- Providing a dedicated BlueReg team highly experienced

in project management, regulatory affairs, writing and publishing activities.

- Oversight of a project manager to ensure consistency and the highest quality.

- Sharing with your company the BlueReg best practice guide and integration kit to make sure that all team members have access to the same level of information.

- Putting in place a robust regulatory intelligence process to ensure compliance with national regulatory requirements.

- Building and maintaining flexible and strong working relationships.

- Development of KPIs and processes for continual monitoring.

- Proposing a quality assurance plan and maintaining a smooth transition between all steps of the project

At a regulatory level- Provision of strategic input on all steps of the registration

process. - Meet regulatory guideline requirements or provide

justification on the deviations present in your dossier.- Interactions and meetings with the Competent

Authorities.- Provision of operational support by coordinating the

dossier preparations including:• Core dossier

- Support in writing updated/compiled CMC, nonclinical and clinical CTD core dossier documents

- Design geographic roll-out plan to align with market launch strategy

• Geographical Roll-Out - tailored dossiers as per local requirements:- Gap analysis of the core dossier vs national

requirements and preparation of any additional required documents

- Preparation of the administrative documents as per local requirements including coordination of legalisation, translations & samples

- Preparation, submission and follow up of active substance and/or manufacturing site registration dossiers when required

- Compiling registration dossiers, publishing & submission to Authorities according to local requirements

- Coordination, preparation and submission of responses to questions

- Follow-up until local approvals- Support for local launch activities

BlueReg SpecialistsBlueReg has a dedicated team of experts in project management, Regulatory Affairs, writing and publishing providing flexible solutions to support your needs on a daily basis. No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need.

Outsourcing Platform on Registration for Export Countries “OPREC”In all these activities, BlueReg will provide you with tailored consulting services

GeographicalRoll Out of

Registrations

Project management

Responses to questions

Collection of local requirements

with support of local affiliates &

partners

Gap Analysis versus Core

dossier

Approval & support for launch activities

Preparation, writing &

compilation of Core dossier

Regulatory strategy &

coordination

Publishing & Submission

Outsourcing Platform on PUblishing & Submission Services “OPPUS”

As an outsourcing and consulting services company, BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). These include publishing Expertise (eCTD, NeeS and Paper Formats), document compliance, gateway submission and project Management supported by the expertise of our consultants and our international qualified partners. We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs and biologicals.


eSubmission Expertise- eCTD / NeeS Strategy and Submission Expertise throughout the World- Expertise in Submission Types other than eCTD and NeeS Formats - Expertise in submitting Baseline Dossiers, ICH E3 eCSR, ASMF and DMF- Submission Portals: EMA Gateway, CESP; FDA & Health Canada Gateway

Zone Expertise- EUROPE - Centralised, Decentralised, Mutual Recognition, National

Procedures, CTA & IMPD- USA - IND, NDA, aNDA, BLA, IDE and PMA- Swiss Medic- NDS Health Canada- Australia- ASEAN, GCC and Rest of the World

Formatting- PDF ready for Submission- Word Formatting for eCTD Compliant Conversion

Project Management- Planning, managing, tracking and ensuring on-time Published Dossier to

meet Submission timelines- Provide advice to optimize Efficiency and Quality- Submission Formats and Publishing Specification updates- Publishing and Formatting on-site Trainings

In all these activities, BlueReg will support you by- Providing a dedicated team of BlueReg consultants highly

experienced in Publishing and Submission activities

- Ensuring project management oversight to maintain consistency and high quality

- Sharing with your company the BlueReg best practice guide and integration kit to make sure that all team members have access to the same level of information

- Putting in place a robust regulatory intelligence process to ensure compliance with worldwide Publishing and Regulatory Submission requirements

- Being involved at every stage of your projects:

• Formatting your documentation according to electronic submission requirements

• Ensuring publishing according to local needs

- Developing processes and KPIs for continuous monitoring

- Proposing a quality assurance plan and maintaining adequate transition between all steps of the projects

BlueReg expertsNo matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need.

Outsourcing Platform on Publishing & Submission Services “OPPUS” Publishing & Document Compliance Tools

Publishing Tools & Expertise- Publishing Tools • Extedo eCTD Manager • Insight Publisher- Validators • Lorenz Validator • EURS Validator • Insight Validator

Document Compliance Tools & Expertise- Adobe Acrobat DC- MS Word- ISIToolbox- PitStop Pro- Quite Revealing- Evermap- Mapsoft

Study CasesPublishing Project- Assign a Publishing Team- Plan the publishing steps and timelines

through meeting(s) with the teams- Check and format the documentation- Publish in BlueReg or Client

environment- Double QC and Validation according to

Country/zone requirements- Transfer of the dossier + Validation

Reports- Submission (If requested by client)- Archiving (GED)- Lessons Learned Meeting

Document Compliance Tools & Expertise- Assign a Document Compliance Team- Prepare the formatting step through

meetings with client- Format your documentation according

to Client/BlueReg requirements- Double QC- Transfer of the formatted

documentation- Lessons Learned Meetings

As an outsourcing and consulting services company, BlueReg is your strategic partner to meet your goals in all types of post-authorisation activities for your medicinal products worldwide.BlueReg provides comprehensive local regulatory affairs services across the world, supported by the expertise of our consultants and our international qualified partners.We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs and biologicals.

Outsourcing Platform on Post-Authorisation Regulatory Services“OPPARS”


In all these activities, BlueReg will support you in:- Providing a dedicated team of BlueReg consultants highly experienced

in post-authorisation activities

- Ensuring a project management oversight to maintain consistency and high quality

- Sharing with your company the BlueReg best practice guide and integration kit to make sure that all team members have access to the same level of information

- Putting in place a robust regulatory intelligence process to ensure compliance with the national regulatory requirements

- Being involved at every stage of your projects: • Writing administrative, CMC, nonclinical and clinical CTD documents • Compiling CTD dossiers as per local requirements • Ensuring publishing according to local needs

- Developing processes and KPIs for continuous monitoring

- Proposing a quality assurance plan and maintaining adequate transition between all steps of the projects

BlueReg expertsBlueReg has dedicated regulatory consultants, highly experienced in all post-authorisation activities, providing flexible solutions to support your needs on a daily basis.

No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need.

Outsourcing Platform on Post-Authorisation Regulatory Services “OPPARS”

Safety and / or CMC compliance project- Assign a dedicated compliance team

- Safety: • Review your reference documents such as CDS, CCDS,

SmPC/USPI versus the current guidelines • Upgrade your reference documents accordingly and set up

gap analysis versus your local SmPC/USPI • Develop regulatory strategy to locally implement reference

texts in your local SmPC/USPI

- CMC: • Review all registered CMC dossiers versus technical reports

issued from your manufacturing sites • Develop appropriate strategy to upgrade CMC dossiers • Prepare & submit the corresponding updated module 3 sections

and QOS as per local regulations

- Launch a geographical roll out of corresponding variations / notifications (preparation & submission)

- Follow up until local implementation

File Lifecycle

Referral

Translation

Renewals

Post-approval commitment management

Interactions with Health

Authority

Variations / Notifications

Line extensions

Pharmaco-vigilance

Product Support

Product Quality Review

Support PV

inspection

Brand optimisation

& lifecycle management

Global promotional

review

Support GMP

inspection

Project management

Regulatory intelligence

Launch activities

PSUSA / PBRER Preparation and submissionPSMF support

Strategy on classification, regulatory planGeographical roll outSafety & CMC compliance project: CCDS/reference document, gap analysisFollow up until local implementation

Ensure local regulatory requirements are metAudit to prepare for inspection

Blue box Serialisation Packaging Promotional review

Perform the review of PQR on behalf of the MAH

Act as PMFollow KPIs and MetricsCommunication with all the team involved

Regulatory review of promotional materials for international congress or “basket of tools” / global product launch

Linguistic review processAdvice on proposed regulatory actions if needed

Outsourcing Platform on Promotional Material Services “OPPROS”

As an outsourcing and consulting services company, BlueReg is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. These flexible solutions range from an integrated package of services to adapted ad-hoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.


Our Services• Regulatory, medical & legal review and validation of

promotional materials at global & local level : - Ensure a complete worldwide coordination with a

project manager as your central contact point - With our worldwide network of local partners, provide

services of local signatories as per local requirements (e.g. ABPI signatory in the United Kingdom, Information Officer in Germany, Regulatory Scientific Services in Italy, Responsible Pharmacist in France…)

• Write, review and revise quality package documents at global or local level (SOP, validation forms, working instructions…)

• Provide advice on the validation workflow, through the choice, configuration and implementation of an adapted software along with the writing and review of related SOPs

• Provide trainings on promotional material review and validation requirements (e.g. for global or local requirements)

Compliance tools IFPMA code, WHO Resolution Ethical Criteria for Medicinal Drug Promotion, EFPIA code, Medical Device Regulation 2017/745 and local regulations such as ABPI code, ANSM recommendations, Medicines Australia Code of Conduct, ANVISA resolutions, Federal Food, Drug and Cosmetic Act ….

BlueReg expertsBlueReg has a team of experts with more than 20 years of experience who are dedicated to supporting your company’s promotional & advertising material activities for drugs and medical devices.

Our clientsOur clients range from start-ups to global pharmaceutical companies, requiring a one-off, repetitive or permanent need for support with activities concerning promotional material review & validation.

Detailed aids & brochures

Disease State Awareness (DSA)

materials

Mailings

E-health applications

WebsitesTV & radio campaigns

Congress materials

Various types of materials

Blue Reg has a team of CMC experts and PMP® project managers dedicated to supporting your company through the full lifecycle of your medicinal products (small molecules, peptides, biologics, ATMP), medical devices and consumer health care products.From product development, through registration and launch into maintenance, we provide flexible solutions or operational platforms to meet your company’s needs.

Global CMC business solutions :Pharmaceutical Development, CMC RegulatoryAffairs & CMC Project Management


Our servicesPharmaceutical development: Supporting the development of the best product while ensuring quality compliance- Strategic consultancy during global pharmaceutical development and lifecycle management- Expertise in all types of API (chemical, biological, herbals) – Development of ASMF, DMF, CEP- Strategic advices in drug product development and coordination of activities as formulation, process, analytical development and validation, specifications, stability studies design, setting of shelf life- Decision making to drive investments: due diligence, gap analysis and experts reviews

CMC Regulatory support: Interacting with authorities at every stage of development and generating associated CMC documentation- CMC regulatory strategy: identify the scientific package needed at each development stage, check consistency between available data and regulatory requirements, perform gap analysis- Scientific advice meetings with health authorities (US/Eur/Export)- Assessment and preparation of regulatory documents : ASMF, DMF, CEP, IND, IMPD, MAA and NDA / BLA module 3, responses to agency questions.- Maintenance of products on market : Post MAA/ lifecycle management with CMC variations

Project management : Coordination of all activities in pharmaceutical development from product development to registration and geographical roll out - Establish project objectives whith client and define strategy for managing the project - Manage risks, control schedule, cost, resources, quality - Manage teams, workstreams, communication (meeting minutes, review of deliverables), changes- Identify, Manage and coordinate analytical or manufacturing subcontractors

When work with us ? The team can cover any step of the product development process, registration as well as product maintenance activities, providing consultancy or hands-on operational support. Interest to have an experienced PM to manage all pharmaceutical activities.

The team Coming from pharmaceutical industry, our CMC experts and senior project managers certified PMP® have a flexible skill set from product development strategy to operational execution, as well as leading and managing projects. We have extensive knowledge of CMC regulatory requirements in an evolving environment. We are flexible and responsive, used to working in an international environment.

Among our latest missions• Subject matter expert for impurities and other analytical

activities• Response strategy to health authorities• CMC expert for the development of a synthetic peptide• CMC variations with groupings• Gap analysis for a Phase III in Europe considering existing

IND for Phase II

INTERNATIONAL ENVIRONMENT

MAA

Early Stage Development Stage ProductMaintenance

Variation

Compliance

Registration

PM activities (TC, meeting minutes, progress reports, planning) - PMP*

Scientific advise meeting, preIND meeting,pre NDA meeting, etc

Coordination of pharm dev activities (galenics, analytics, scale-up, stabilities, preclinical & clinical studies)

Coordination of subcontractors CMO/CDMO from APIto registration batches

Development strategy (dedicated PM)

Geographicalroll out

Module 3IND/IMPDDMF/CEP


Scientific Writing


Our services• Pre MAA EU / US: ODD requests, PIP/ PSP, INDs, Scientific advices

briefing packages (for National/EMA Scientific Advice, FDA meetings, oral hearings…), Investigator brochures and annual updates, Safety reports (DSURs, IND annual reports), Target Product Profile

• EU / US MAA: All Modules for the Common Technical Documents (CTDs), including Summaries and Overviews for EU MAA/NDA/BLA, Risk Management Plans and Product Information/ prescribing information.

• Response to question from Regulatory Authorities

• Post MAA / Life-cycle management life cycle management: Variations (pharmaceutical, clinical…): CTD modules updates, Periodic Benefit-Risk Evaluation Reports …

When work with us?The team can cover any step of the development process, providing consultancy or hands-on operational support.

Among our latest missions• Writing clinical modules for submission in EU and US

• Writing PIPs, ODDs, INDs, IMPDs…and IBs

• CMC writing for chemicals and biologics

The teamA team of experienced consultants and scientific writers with significant experience in the pharmaceutical industry.


Why work with us?Our team hold a flexible skill set ranging from development strategy to operational execution, as well as leading and managing projects and expertise in CMC, non-clinical and clinical. They can also work closely with other specialists in BlueReg to provide an integrated development and regulatory service.

Scientific Writing

Blue Reg has an experienced team for PQR writing including CMC, Quality & Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.From data gathering, through data analysis and PQR writing, we provide flexible solutions to meet your company’s requirements.

Product Quality Review Exploitant (PQR)


Product Quality Review Exploitant (PQR)

QUALITY SYSTEM: BlueReg Internal SOP or Client SOP

Data Analysis- Compliance to GMP requirements- Critical review of batch data evaluation performed by the manufacturer- Evaluation of the overall quality of the product - Assessment of the consistency of the existing manufacturing process- Highlight of any trends- Review of the proposed CAPAs, highlighting action plans to be monitored or added- Verification of the consistency between local data and information provided by the manufacturer

Project Management

Effective communication with the client

Setting up and monitoring review

schedule Writing the PQR for the « Exploitant »- In accordance with the review template provided by the client or using BlueReg template- Assessing manufacturer results and setting conclusions on process control- Providing a global assessment on the local data and the evaluation done by the manufacturer

Data Gathering- Manufacturer PQR- Local data (ie. variations, deviations, contracts, complaints, recalls)

The teamA team of consultants from Quality, CMC and Regulatory Affairs with significant experience in the pharmaceutical industry who can help you to design the appropriate support you need.

Our clientsGlobal pharma companies with punctual, repetitive or permanent need for support, both «exploitants» and marketing authorization holders.

Why work with us?Our experienced team members are trained regularly by PQR and GMP training courses. They have more than 5 years of experience in PQR writing for various clients (about 250 PQRs written in 2018 for 4 clients).

Our servicesPQR is a regulatory requirement (EU-GMP chap 8, US 21 CFR part211, ICHQ7A, GMP for adding the exploitant responsibility) and an effective quality improvement tool to verify annualy the consistency of the existing process & overall quality of the product. These PQRs are assessed deeply by inspectors during Health authorities inspections and should be carefully managed by trained and knowledgeable people.BlueReg can help you to set up the PQR process in your company and/or manage your annual reviews.We propose the following approach, to be adapted and designed according to your request.


France Local Regulatory, Quality & Pharmacovigilance


Our services• Interaction and meetings with the French Authorities (ANSM)

• Regulatory support for clinical trials

• Early access programme (ATU): Ad-hoc advice, Preparation of the ATU application, Submission of ATU dossiers to ANSM and follow up until ATU is granted, Day-to-day management of ATU programmes, Generation and submission of ATU periodic reports

• Advice and operational support for commercialisation of drugs in France: Pharmacovigilance, Supply chain, Review of promotional materials, Review of packaging materials, Market Access, Compliance of the interactions with HCP (DMOS), Assistance in the certification of Sales Representatives (Charte de la visite médicale)

• Advice and support for “Exploitant” activities: to obtain and maintain Exploitant license in France including writing SOPs and product quality reviews.

When work with us?For any types of projects even the most sensitive and complex.

Among our latest missions• Review and submission of promotional materials for pharmaceutical

products and medical devices

• Preparation of a cohort ATU (early access) application For an Orphan Drug

• Handling of all local regulatory activities for a portfolio of pharmaceutical products

The teamA team of highly qualified consultants with significant hands-on industry experience including experts in Regulatory Affairs, Quality management and Pharmacovigilance.


Why work with us?A “France” dedicated team with significant Regulatory, Quality & Pharmacovigilance experience.They can provide expert advice followed by hands-on operational activities.

FranceLocal Regulatory, Quality & Pharmacovigilance

Blue Reg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France.From pricing & reimbursement strategy to submission to the Authorities, we provide flexible solutions to meet your company’s needs.

Market Access France


Our servicesWe guide you at each stage of the pricing and reimbursement process in France (medicinal products and medical devices):Strategic consultancy for pricing & reimbursement:- Recommendation on reimbursement and pricing strategy- Expertise through the complete reimbursement process: new drugs,

extension of indications or reassessmentPricing & reimbursement application support: - Writing of reimbursement dossiers for the French National Authority for

Health (HAS) (new registration, renewal, change of registration conditions, reassessment)

- Writing of pricing dossiers for the French Economic Committee for Healthcare Products (CEPS): new registration, price increase

- Compilation and submission of the dossiers- Interaction with authorities at every stage of the reimbursement process

When work with us?The team can cover any step of the pricing and reimbursement process, registration as well as product maintenance activities, providing consultancy or hands-on operational support.

Among our latest missions• Strategic consultancy for pricing & reimbursement for a company

launching an innovative medicinal product on French hospital market• Writing of pricing & reimbursement files for a new medical device• Preparation of a meeting with the French National Authority for Health

(HAS)

The teamA team of experts, project managers and scientific writers with significant experience in the pharmaceutical industry and the consulting.


Why work with us?Our pricing & reimbursement team members have a flexible skill set ranging from product reimbursement strategy to operational execution. They are available to support you through the pricing and reimbursement process for medicinal products and medical devices.

Market Access France


Pharmacovigilance


Our services• Pharmacovigilance organisations and systems: Setting up

pharmacovigilance system, Preparation of Pharmacovigilance System Master File (PSMF), Procedures and Safety Data Exchange Agreements (SDEA), QPPV services.

• Pharmacovigilance / safety documents: Assessment a product’s risk benefit profile, Writing and maintenance of RMP in accordance with GVP Module V, Writing of DSURs, PBRERs..

• Pharmacovigilance audits (PV audits) and inspection support: SOP reviewing/writing, Conducting audits of sites (internal/third party) and mock audits, Support on-site during the audit, Pre-audit training to staff.

When work with us?The team covers the whole development process as a consultant or operational support, from concept to approval, on a global or multi-national projects.Do you have peaks of activities? Let us manage your safety reports. You wish to set up a PV service or outsource your PV activities PV? BlueReg has experts and tools to address your questions and needs.

Among our latest missions• Implementation of the PV system for a new pharma company, including

drafting PSMF and procedures, staff trainings…

• Management of all the PV related activities for a Biotech company including case processing, safety reports and provision of a qualified person in PV.

The teamA team of highly qualified consultants with significant hands-on industry experience


Why work with us?Our team hold a flexible skill set ranging from strategy to operational execution, as well as leading and managing projects.

Pharmacovigilance


Brexit


Our services• Support / advice to MAHs established within the EU/EEA or in UK

• Planning activities, process adaptation, variations considering the procedural timelines to avoid any impact on the continuous supply of medicines

• Check compliance for and impact on:

• MAH/Applicant

• RMS for MRP/DCP

• QPPV

• ASMF

• Batch testing and batch release

• Any other changes (e.g. updates to wholesale dealer authorisations for import/export from a third country)

When work with us?The team can cover any aspects of Brexit, providing consultancy or hands-on operational support.

Among our latest missions• Full integration of our consultants within project teams

• Management of Registration Procedures in MRP, DCP or CP

The teamA team of experienced consultants with significant experience in the pharmaceutical industry.


Why work with us?Our team hold a flexible skill set ranging from strategy to operational execution, as well as leading and managing projects.

Brexit


• Pharma Blue provides «Exploitant» services to pharmaceutical companies looking for a partner to launch their drugs on the French market• PharmaBlue holds an “Etablissement Pharmaceutique Exploitant” license from ANSM and as such can take over the organization and supervision of the distribution in France of pharmaceutical products, including advertising, information, pharmacovigilance, batch follow-up, and if required, batch withdrawal operations.

PharmaBlue • Partner with Pharmaceutical and BioTech Companies

• Act as «local exploitant» for launching medicines

on the French market

ATU : Early Access to Innovative or Orphan drug productsPharmaBlue provides the “exploitant” support using BlueReg resources to handle required activities• Provision of ad-hoc advice or responding to specific questions,

including strategy and/or positioning of ATU projects.• Preparation or review of ATU application including the protocol

for therapeutic use (PUT)• Submission of ATU dossiers to ANSM and follow up until ATU

granted• Day-to- day management of ATU programme: Patient inclusion

and follow up, validation of the pharmacist orders, processing and capturing of all collected data

• Generation and submission of ATU periodic reports

AboutPharmaBlue

The exploitant status a Market specificity in France

• Under the French legal framework, an operator that wants to market a medicinal product in France should hold an Exploitant status or partner with an Exploitant. The Exploitant operator is one of the pharmaceutical establishments authorized and regularly inspected by ANSM (French competent authority).

• Exploitation is a pharmaceutical status that applies to commercial operations for medicinal products in France. In charge of placing the medicinal product on the market in France, the operator must ensure that all pharmaceutical activities associated with the products for which it is responsible are carried out in accordance with the applicable provisions.

A BlueReg Company« Pharma Blue benefits from the expertise of BlueReg consultants who can provide advice or support to comply with the regulatory requirements and best practice obligations to market a pharmaceutical product in France »

« Exploitant »

Pharma Blue is certified by ANSM in France as an “Exploitant”• Supports pharmaceutical companies for the marketing

in France of their medicinal products which have been granted an early access authorization (ATU) or a marketing authorization (MA).

• Manages local pharmaceutical activities including regulatory, quality, medical information, pharmacovigilance, batch follow-up..

• Medium / long term partner providing Exploitant services to clients for fast market access in France of their approved medicines (Orphan or unmet medical need)

Medical Devices Business Solutions

As a consulting services company, BlueReg is your strategic partner to meet your goals in Medical Devices development, maintain regulatory compliance and achieve worldwide registration. BlueReg provides tailored solutions for each lifecycle step for all types of Medical Devices, including: implantables, drug-device combinations, complex and borderline products. These solutions range from an integrated package of services «from the idea to the market», to adapted ad-hoc regulatory and technical support. Our goal is to explore innovative approaches to provide relevant advice to ensure you maintain your competitiveness in this complex and rapidly changing regulatory environment. BlueReg’s vast range of experts, from our multidisciplinary team and international partners, work in synergy to ensure global management of your projects.


PR

OD

UCT

Design Industrialisation CE Marking Marketing- Feasibility- Regulatory strategy and/or

classification- 21 CFR Part 820 (DHF/

DHR)- Input/output matrix- Pre-clinical evaluation

(biocompatibility, risk management, usability, design verification and validation)

- Clinical evaluation/clinical investigation

- Labelling, UDI

- IQ, OQ, PQ- Special process validation- 21 CFR Part 820 (DMR/

VMP)- Transit validation- Subcontractor

specifications- Contractual relationships

with subcontractors

- Conformity to essential requirements

- Technical file/STED- CE Marking file

submission to Notified Body follow-up

- Worldwide registration roadmap

- Local requirements

- Promotional material - local requirements

- Design changes & process changes (management, submission and follow-up)

- PMS/PMCF and Vigilance- Liaison with Health

Authorities and Notified Bodies

QU

ALI

TY

Quality Management System- Compliance with relevant standards- Implementation, update following audit, CAPA, standards evolution- Support during audit- Contractual relationships with economic operators

- Define Medical Device status of a product

- Analyse all relevant applicable standards

- Set up plans for appropriate testing- Set up validation plans- Set up clinical investigations

- Determine and set-up preclinical evaluation

- Create the technical file- Update and maintain the technical file- Submit CE Marking file

- Update documents according to regulatory intelligence

- Worldwide promotional review- Management of process and design

changes- Support worldwide registration

BlueReg expertsNo matter how complex your requirements, BlueReg’s highly qualified consultants can provide you with the appropriate support you need.

Compliance ToolsISO 13485, ISO 14630, IEC 62366, ISO 14971, ISO 10993 Serie, ISO 14155, ISO 15223, ASTM, AAMI standards and common specifications.

Study cases:

Be in time for the MDR Medical Device Regulation 2017/745

BlueReg is an international consultancy company specialised in development, regulatory affairs, quality management and pharmacovigilance for the pharmaceutical industry. We are recognised for our tailored consulting services including expert advice with hands-on operational execution. We have developed long term partnerships with key-players in the pharmaceutical industry using a multitude of IT systems and processes.Following increasing requests from our clients, we are now providing a wider variety of IT services to support our customers related to the technology, systems and operations underlying the Pharma industry.

Pharma Information Technology and Systems Services


Regulatory InformationManagement System

Clinical TrialMaster File

Pharmacovigilence

Electronic DocumentManagement System

Regulatory Pharma

PV

EDMS RIMS

eTMF

Publishing

PromotionalDocuments

eXtended EuduraVigilence Medicinal product Dictionary

Anonymisation, identification & redaction of commercially confidential information in clinical reports

Computer System Validation for 21CFR part 11

Identification of Medicinal Products

GMPAnnex 11

IDMPxEVMPD Compliance

EMA Policy0070

Pharma InformationTechnology and SystemsServices

Our ServicesWe can provide comprehensive services including Audits, support for Software Selection, Project Management, Change Management, Implementation, Training & Hosting.

Our clientsCurrent customers of BlueReg, include small Pharma such as Biotech companies who are impacted by the evolution of regulatory requirements in the world of pharma (eSubmissions) and global digitalisation

Why work with us?BlueReg has an experienced team of IT professionals who are dedicated to supporting your company in all IT services related to the pharma industry.

We cover all aspects of regulatory through to compliance, manufacturing, clinical trials and global IT services and we provide flexible solutions to meet your company’s requirements.

Date post:	28-Jul-2020
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