• Regulatory Consultancy for
    Bio-/Pharmaceutical Companies

  • Authorization of Medicinal Products

  • Interim Management
    Regulatory Affairs

  • GxP Audits

  • Dossier Compilation

  • Scientific Advice

  • Due Diligence

Credentials

“Working with BioReg was an absolute pleasure. We undertook a very complex acquisition of a manufacturing site, FDA approved vaccine and numerous other assets. Ute and her team were instrumental from initial diligence, to helping define the assets to purchase, to developing the quality and regulatory integration plan and delivering the initial Quality System for the new organization. A big success, this acquisition, only possible with BioReg’s assistance, transformed our company.”

Nima Farzan

President & COO PaxVax, Inc

“BioReg Consultancy is a highly reliable and fully dedicated advisor and a much valued part of our development team that successfully moved our lead product – a monoclonal antibody construct - from research into clinical trials Phase I in the EU and the USA.”

Rolf H. Günther MD

PhD, CEO, Affimed Therapeutics AG, Heidelberg

“BioReg Consultancy played a key role in successful management of submissions for plasma product applications of our company.”

Michael Soldan

PhD, Geschäftsbereichsleiter Medical/Regulatory Affairs,
Biotest AG, Dreieich

“During the development phases of our vaccine candidates and biotechnological products Dr. Ute Krahl has been providing very valuable strategic advice in manufacturing and regulatory affairs matters. With her excellent strategic and hands-on support to the team VPM managed to develop a live recombinant vaccine from bench to man in less than four years.”

Bernd Eisele

MD, CEO Vakzine Projekt Management GmbH