Regulatory Archives

National Marketing Authorization Applications

by Nick | 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 Nick | 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 Nick | 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...

Chemistry, Manufacturing & Controls

by Nick | Mar 5, 2021

Chemistry, Manufacturing and Controls (CMC) Regulatory Support Biomapas Regulatory team has the practical experience and essential knowledge in every aspect of Module 3 Quality, offering the preparation of the full document, post-authorization changes assessment,...

Dossier Development / Medical Writing

by Nick | Mar 5, 2021

Dossier Development / Medical Writing Our medical writers are qualified scientists with PhD degrees in biomedical sciences and experience in the pharmaceutical industry, clinical research organizations or academia. Biomapas’ Medical Writers may support you with the...

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National Marketing Authorization Applications

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National Marketing Authorization Applications

Local Regulatory Affairs Support EAEU/CIS Region

Marketing Authorization Applications (EU / EMA)

Chemistry, Manufacturing & Controls

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