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Regulatory Strategy and Dossier GAP Analysis

by | Mar 10, 2021

Regulatory Strategy And Dossier GAP Analysis Regulatory Strategy We set you up for regulatory success by managing the entire process from dossier writing to filing applications. Biomapas’ experienced regulatory affairs specialists hold an unmatched reputation...

eCTD & NeeS Compilation

by | Mar 5, 2021

eCTD & NeeS Compilation Biomapas provides full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software. Our team is fully prepared for new requirements...

National Marketing Authorization Applications

by | Mar 5, 2021

National Marketing Authorization Applications Decentralised, Mutual Recognition, National Procedures We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing...

Local Regulatory Affairs Support EAEU/CIS Region

by | Mar 5, 2021

Regulatory Affairs Support in EAEU Region Our experts are qualified scientists with extensive experience in the pharmaceutical industry and clinical research. We provide registration procedure services in all Eurasian Economic Union countries, starting from medical...

Marketing Authorization Applications (EU / EMA)

by | Mar 5, 2021

Marketing Authorization Applications Biomapas provides local regulatory affairs support to clients in both pre-authorization and post-authorization regulatory affairs across Europe. Our full range of Regulatory Affairs solutions is dedicated to delivering the highest...

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

Clinical Research

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Regulatory Affairs

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Pharmacovigilance

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Medical Information

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