by Anna Kamocsai | Jan 5, 2021
Home 9 Page Category: Regulatory ( Page 2 ) Regulatory Intelligence Biomapas’ regulatory intelligence services allow you to formulate a feasible drug development, clinical, and commercialization strategy. Our years of experience in monitoring, obtaining and...
by Anna Kamocsai | Sep 10, 2020
Pharmacovigilance System Set-Up & QPPV Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System We...
by Anna Kamocsai | Jun 10, 2020
Benefit-Risk Management Every product’s benefit-risk balance is under continuous review. Regulators expect you to show that you understand it, manage it and act on new evidence quickly. Our pharmacovigilance team works as an extension of yours, using structured...
by Anna Kamocsai | May 10, 2020
Global and Local Literature Monitoring Global and local literature monitoring plays a critical role in identifying reportable Individual Case Safety Reports (ICSRs) and detecting emerging safety signals. Biomapas provides comprehensive post-authorisation...
by Anna Kamocsai | Feb 10, 2020
National QPPV / LPPV Network With its wide Local Safety Officers (LSOs) network, Biomapas can fulfill all and any local Marketing Authorisation Holder’s obligations in EU and non-EU countries and perform all local pharmacovigilance representation activities,...
