by Nick | Oct 8, 2020 | Regulatory Affairs
In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing...
by Nick | Oct 2, 2020 | Pharmacovigilance, Regulatory Affairs
With the growth of social media network users all over the world, there is no doubt that one of the most accessible and widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people...
by Nick | Aug 12, 2020 | 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...
by Nick | Aug 6, 2020 | Regulatory Affairs
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...
by Nick | Jun 17, 2020 | Regulatory Affairs
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...
by Nick | May 14, 2020 | 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...
