CMC service and advice on Strategic, Tactical and Operational level!

Based on more than 30 years’ experience in Biotech and Pharmaceutical development AVP BioPharma Consult ApS was established in 2015 as an independent consultancy company in the area of Biotech and Biopharma product development, CMC documentation, regulatory filing etc.

A combination of in-depth technical understanding and development process overview is crucial for efficient project handling, and finding the optimal balance between doing everything “full blown” and getting sufficient speed in the projects can be difficult.

Being in "Big Pharma" or in small Biotech can be very different, and focus and priorities might differ – whether primary focus is “time to market” or “result enabling the next financing” etc. Postponing certain investigations can be beneficial or it can be a major mistake to do so - it can even be jeopardizing the entire company!

However, more important than anything else: The safety of the patients and volunteers must never be at risk!

No-one can claim to have all the right answers, but experience from small Biotech as well as established Pharma companies can help giving directions – and maybe most important, help raising the questions that are important for being able to make the right decisions in due time.

Being independent but connected with several formal and informal specialist- and consultancy networks, offers the opportunity to involve the relevant expertise.

Through a flexible approach, it is possible to offer scalable solution and adapt to the specific needs as well as to the changing environment of the customers.