by Anna Kamocsai | Mar 21, 2021
Safety Database & Workflow Integration A modern safety platform built for scalable pharmacovigilance Biomapas uses Veeva Vault Safety, a cloud-based platform, to support pharmacovigilance and clinical safety operations with real-time oversight and integrated...
by Anna Kamocsai | Mar 10, 2021
PSMF Development & Maintenance A Pharmacovigilance System Master File (PSMF) summarizes your pharmacovigilance (PV) system and is a critical document for any Marketing Authorization Holder. To comply with EU PV legislation requirements, all MAHs and MAH applicants...
by Anna Kamocsai | 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...
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...
