by Anna Kamocsai | 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...
by Anna Kamocsai | 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...
by Anna Kamocsai | Mar 5, 2021
Regulatory Affairs Support in EAEU Region Our experts are qualified scientists with extensive experience in the pharmaceutical industry and regulatory affairs. We provide registration procedure services in all Eurasian Economic Union countries, starting from medical...
by Anna Kamocsai | 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...
by Anna Kamocsai | 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,...
