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ABC Biologics Q u a l i t y p a r t n e r s
ABCBiologicsQ u a l i t y p a r t n e r s
Corporate presentation-2017www.abcbiologics.com
Corporate office: H.No-11-20-28, Kothapet, Hyderabad-500035
ABC Biologics founded in the year 2015 to meet the needs ofcontractual services with CROs and pharma companies across theglobe.
ABC Biologics is operating by young entrepreneurs and experiencedprofessionals in CRO business.
ABC Biologics
www.abcbiologics.comwww.abcbiologics.com
“To be ensure efficiency, quality, transparency and confidentiality of the services and become the only choice of global partner for
all Clinical services and provision of expert data solutions that meet current and future development needs"
RelationshipsTo enhance positive working relationships based on trust
and collaboration and believe in one global team.
ExcellenceWe strive towards to
demonstrate excellence to both our customers and
colleagues.
AccountabilityPersonal responsibility for
delivering results by following a process of seeing it, owning it,
solving it and doing it.
Customer-FocusProviding a service focused
approach in all of our interactions.
www.abcbiologics.com
VALUES AND VISION
MISSION
www.abcbiologics.com
We commit ourselves to total sponsor care by delivering world-class auditing services.
We want our customers to want to work with us and to see us as a true extension of their clinical team and this will be achieved through a combination of:
Being seen as an integral part of the partnership development team
Being passionate and proactive
Having staff that want to add value to our business and clients
Delivering quality outcomes
“Combine the strength of experience, innovation to provide the world class services for CRO and pharmaceutical industry"
www.abcbiologics.com
SERVICES“Our approach is to provide guidance alongside our deliverables. We are involved from the design of a study through to final
submission"
AUDITS
MEDICAL WRITING
REGULATORY AFFAIRS
BIOSTATISTICS
SERVICES
TRAINING & CONFERENCES
AUDITS
www.abcbiologics.com
BIOANALYTICAL PHASE:
We are experts in Bio analytical data review and it’s compliance to the industry standards.
To assess laboratory practices as per GLP regulations, adherence to the predefined internal standard operating procedures and otherregulatory standards.
CLINICAL PHASE:
Our Clinical phase monitors have real time experience in BA/BE clinical phase CRO`s.
To ensure the conduct of study in compliance with regulatory, protocols, SOPs, contracts, agreements and other written procedures.
SITE QUALIFICATION:
ABC Biologics assists in selecting the CRO and qualifying them by conducting System and Facility audits with well experienced professionalsfrom regulatory environment.
“Our audit strategy ensures your quality compliance with regulatory standards to create benchmark in the industry"
REGULATORY AFFAIRS
www.abcbiologics.com
ABC Biologics working across the globe for various regulatory bodies which includes USFDA, UKMHRA, ANVISA, EMEA, ANSM, etc.,
We work as per all regulatory specifications- guidelines, rules and regulations of the required authority across the globe.
We are strongly emphasis on fast deliverables for early submission of projects and get approvals.
We assists the clients in drug master , site master filing and applying no objection certifications for DCGI and other regulatory bodies. Apart from theses services, we also work on answering various quarries relates to regulatory audits and dossier preparation and submissions for USFDA, EMEA.
“Our Regulatory affairs guide your organisation and adherence to laws, regulations, guidelines and specifications relevant to its
business "
ABC Biologics have skilled professionals in medical writing can craft the effective report to get approved by regulatory authorities and get accepted by international journals.
We work prominently on regulatory guidelines and international journal specifications to get assured acceptance without major observations.
We have unique review process to ensure presented data is accurate and precise as per specifications.
We works on protocol writing, integrated data report, research journals, article writing and SOP preparation.
We also works on investigator's brochures, poster preparations
www.abcbiologics.com
MEDICAL WRITING
B
“Our Medical writing services describes all the research results in the report to get global acceptance"
www.abcbiologics.com
BIOSTATISTICS
ABC Biologic’s Biostatistics services offer wide range of statistical analysis with knowledge and experience.
We have highly qualified biostatisticians from statistical context by education and experience frequently associated in large number of statistical analysis.
We offers Pharmacokinetic, stastical analysis, Randomization of subjects and blinding QCs during clinical and bioanalytical phases.
“Our Biostatistics develops the best study designs to minimize the study cost and navigate fast deliverables "
TRAINING & CONFERENCES
www.abcbiologics.com
ABC Biologics conducts Training and Conferences across the globe to create innovation in young scholars and research scientists.
We conduct GCP, GLP, GMP, and GDP Training programmes for CRO working professionals
We conduct the conference across the globe on recent issues of regulatory affairs and research topics to bring commonality in the industry practices and approaches
Our organizing skills are unique to bring expert speaker from the industry and academics to make the conference adorable.
We provide certification and required key notes for conference and training attendees.
“Our Training and Conferences aimed to bring the innovation and develop the scientific knowledge at academics and research"
www.abcbiologics.com
Contact us:Balaraju Edem (Director) Phone: +919030435853
Email: [email protected]@abcbiologics.com
Website: www.abcbiologcs.com
THANK YOU
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