- Prosfora provides Compliance services (QMS) to Clients and has aided 50 Pharma sites (API+FDF) ensure regulatory compliance (source). Why does this business model work? Why can Pharma companies not conduct QMS services in-house?
Sahil’s Notes: We could also optionally add leading questions like is this due to Economies of scale, but imo those tend to steer the conversation towards the speaker’s biases, away from the speaker’s experiences. - You’ve worked with Wokhardt, Alkem, Kopran, and now Prosfora (for the clients) in the Regulatory compliance kind of role. Across all these companies, what are a set of generalizable processes and learnings that you can share, about what companies can do to stay on the right side of regulatory compliance?
- Does luck or randomness play any role in regulatory compliance? Is there subjectivity in FDA (and similar) guidelines which can result in non-compliance or is this completely a function of the investments made by the company (money, personnel, headspace) for compliance?
Will try to think about more questions. @harsh.beria93 do you already have a date in mind when you’re talking to Amit? In that case I’ll work backwards from that date. How long would the interaction be? I ask this so that I can understand roughly how many questions you’re looking for.