How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?
It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments...
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...
What do you need to know while preparing RMP for EAEU and CIS region?
Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements...
