your global support in EuropeOver 20 years of experience

ELM Pharmaceutica

ELM Pharmaceutica

Consultancy company established in 1995 and set up by a

multidisciplinary active team of professionals with over 20

years of experience in bio-pharmaceutical industry.

Provides services from early development, best regulatory

strategy up to marketing and beyond to companies wishing

to launch medicinal their products in EU market.

ELM has the required legal authorisation and organisation

in-house to act as your EC company, saving initial

unnecessary costs in a cost efficient and timely way.

ELM Pharmaceutica

Development

Dossier in

European form

Marketing authorization in

UE

MarketingStrategic

application and tracking

Price and reimbursement

Registration dossier and European legislation

Transfer/facilitation

companies:Import

Distributor Manufacturer

PharmacovigilancePromotion control

Clinical-preclinical trials/CMC studies

Life cycle maintenance

Manufacturing plant EU

authorisation

Advice, Coordinate, Manage, Facilitate: From Development to Marketing

Internally

Through companies and research centres

Multidisciplinary team having outstanding experience in:

• Business development• Management and strategic consulting • Clinical, non clinical, CMC and PhV requirements for

final EU authorisation• LATAM pharmaceutical market• EU regulatory and legal activities through a

regulatory website• Regulatory policy

HOW Our team: our strength

Regulatory Pharmacovigilance

Carla Besó +

EU Development

Jordi Ruiz

External relations Latam Countries

Xavi Perez

Elisabeth Lopez

Business strategy

A long term detailed planning

Early definition of deliverable quality and efficacy criteria suitable for

EMA/FDA approval

Large experience with EU regulatory agencies of drugs, medicinal food

supplements and medical devices

Large experience in project coordination

Commitment to success

Connected to EU research and development centers

Large experience in EU national and transnational studies

Areas of expertise• Life sciences (bio-pharmacy, veterinary science, cosmetics, nutrition,

medical and environmental devices)• Early detection kits development

HOW: A strong network

AbbcnDevelopment of IVD

ELM PharmaceuticaDevelopment regulatory/ EU approval

Methodex

Lorien

MAHEnoc

Liposomal develop/

production

Liposomed developments

ELM lifescience: A strong network

Development studies

We have contacts and experience with public Universities,

Hospitals and private centres within Europe to perform

clinical, preclinical, quality control analysis and

characterisation of actives according to EU legislation in a

cost efficient and timely way.

A tailored made service that allows client to decide its

degree of participation.

Areas of activity: advice, coordination and managing

Regulatory activities

Insight the company and through a regulatory web around

Europe

From due diligences of registration dossiers, manufacturing

plant authorisation, European registration procedures

(MRP, DCP, centralised or national), Marketing

authorisation application, scientific advice meetings and

other Agency contacts to price and reimbursment.

Areas of activity: advice, coordination and managing

Pharmacovigilance

Authorised by Spanish Agency and audited by our clients

we can take over pharmacovigilance responsibilties,

carrying out all pharmacovigilance activities in

compliance with UE and in close relation with MAH

requirements.

Business enhancing

Identification of potential business partners from

manufacturing transfer or import- batch release regulatorily

necessary for commercialisation in EU, to distributors or

wholesalers, licencees…..

From small start up companies to big pharmas wanting to enter EU market

Our clients

usa

Local Responsible/MAHDue diligencePharmacovigilanceBioequivalencePharmaceutical developmentBioequivalence studies monitoring and coordination Clinical metanalysisScientific advicesMedical writingManufacturing plant EU authorisationSubmission application

Most of our clients are long term

CNCE INNOVACION SL

Contact:

ELM Farmacéutica

Valencia 231, Ático 2ª

08007 Barcelona

Phone: 932152006

Fax: 934677147

Email: info@elmpharm.com