Biomapas appoints Head of Global Regulatory Affairs
May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution...
Regulatory Documents Translation Process – How to Ensure Consistency and Correctness
Mistranslation of regulatory documents such as common technical documents dossiers, a summary of product characteristics, labelling, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to...
Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships
The trend of outsourcing continues to grow in the life science industry. In particular, the global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018 and is expected to witness a compound annual growth rate of 11.9% over the period to...
Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch
In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When...
