Jan Gunnar Gustafsson is a versatile and highly accomplished Senior Executive Management Professional offering over 32 years’ experience in the areas of Process Development, Strategic Planning, Creative Solution Development, Manufacturing, Organizational Health & Safety Management, Contract Negotiation, Quality Assurance and Project Management in the Pharmaceutical industry.

He is also a Biopharmaceutical Expert, Scientist and a Strategic Business Development Manager with extensive leadership & management skills and rich exposure to Swedish, American and European markets.

Regulatory expertise: He has a core knowledge based on 21 years of formal, theoretical and practical know how of biopharmaceutical requirements. Have been responsible for fulfilling regulatory requirement during development phases and manufacturing for clinical trials and commercial manufacturing, including cGMP regulation rules, also Quality Assurance. Responsible for setting up specifications for in-process, API and DP, adapted to requirements for phase I – IV. Have written the CMC part in IND, NDA, BLA, EMA and IMPD applications for clinical trials, also DMF, Drug Master File. Taking part in pre-meeting with FDA Have a good understand of present branch requirements for biopharmaceuticals, regarding regulatory, cGMP, documentation and registration requirements.