CMC: Best Practice in Effective IND and IMPD writing
Previously, we have discussed the importance of dedicated team for CMC writing as well as project management aspects for effective IND/IMPD writing (previous text here). This time we will focus on technical writing and preparation for it. Also, I will provide some...
CMC: Effective Writing of IND and IMPD
Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to...
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...
