Excellence in Drug Regulatory Affairs

About us

Dr. Hofer founded EXDRA in 2002. Since then, EXDRA worked successfully with a variety of small, medium-sized and big pharma companies on diverse projects in the life science sector in the EU, USA and Japan.


Together we are even better
In 2023, Dr. Jan Heun has started to support EXDRA as Partner in the field of regulatory consulting and product development. This has expanded capacity and know-how in additional subject areas and will enable EXDRA to fulfill its premise of understanding your regulatory objectives as a holistic task even better.


Dr. Josef Hofer

Managing Director

  • Pharmacist by education
  • PhD in pharmaceutical Technology
  • 40 years of experience in the regulatory environment
  • 14 years in senior positions in Pharmaceutical Development, Innovation management and Drug Regulatory Affairs
  • 7 years as Director International Drug Regulatory Affairs for Klinge Pharma and later Fujisawa, Germany
  • since 2002 Managing Director exdra GmbH
  • Guest lecturer for the University of Marburg and Tübingen, Germany
  • Regular Lecturer for the University of Bonn and founder of the MSc program for Drug Regulatory Affairs
  • Lecturer for international training courses on Quality, GMP, Regulatory Intelligence and Business Development


Dr. Jan Heun


  • Chemist by education
  • PhD in Immunology/Oncology
  • ~ 25 years of experience in the regulatory environment
  • > 20 years in senior positions in the pharmaceutical and medical device industry in Regulatory Affairs and Project Management,
  • Information Officer according to § 74a (German Medicines Act) and § 56 (Austrian Medicines Act)
  • Active member of various German Associations in their Regulatory Affairs committees (BPI, vfa and BVMed)
  • Leader of Modul 1 and Lecturer of Master Drug Regulatory Affairs study course at University Bonn

As Head of Regulatory Affairs, Information Officer and Regulatory Affairs Manager of several international pharmaceutical and medical device companies (Baxter, Chiron Vaccines (Novartis Vaccines, now GSK), Aventis (CSL) and  Oncomedica), Dr. Jan Heun brings nearly 25 years of experience in the field of various drug and medical device developments, project management and market access (AMNOG). These include a product range from anesthetics, antibiotics, dialysis solutions and devices, vaccines, parenteral nutrition solutions to recombinant and plasmatic blood products as well as veterinary drugs. His expertise in product development has been demonstrated in valuable scientific advice meetings with all three German regulatory authorities (BfArM, PEI and BVL), as well as with various European authorities and with the Agency (EMA).

Dr. Heun is a member of DGRA and MEGRA, was active as company representative in the Regulatory Affairs committees of different trade associations (BPI, vfa  and BVMed) and has been active in the 1st Regulatory Affairs circle for many years. He also heads Module 1 of the Master’s program Drug Regulatory Affairs at the University of Bonn.