audits

The Pharmacovigilance System Master File (PSMF) stands as a crucial document in the realm of Good Pharmacovigilance Practice (GVP). It has been a cornerstone of the guidelines put forth by the European Medicines Agency back in 2012. Regular ad-hoc reviews of the PSMF are a common practice, particularly during audits or due diligence processes. It […]

By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss about the non-compliance areas, but provide considerations for the marketing authorization holder (MAH) for ensuring compliance. Every MAH can’t have commercial operations in every country in which it holds licenses. This may even […]

In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days. In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize […]

Not all companies would consider setting up affiliate offices/ subsidiaries in all countries where they wish to operate or commercialize products. The Pharma company may consider nominating a distributor or business partner in such scenarios. Besides, companies may even consider co-marketing arrangements in countries already operating, using own-label or private-label supplies or other means such […]