• Regulatory Consultancy for
    Bio-/Pharmaceutical Companies

  • Authorization of Medicinal Products

  • Interim Management
    Regulatory Affairs

  • GxP Audits

  • Dossier Compilation

  • Scientific Advice

  • Due Diligence


The greatest regulatory need in small, start-up companies is product development planning. You do not know what you don’t know. Just reading the guidelines does not help to find the best solution for your product.

Large organisations with new products or the need to get changes to the quality, safety or efficacy approved by variations often need project dependent interim support. GMP compliance requirements are continuously widened by authorities. Make sure, your manufacturing and control process complies right from the start of the development through life cycle management.

Rely on a dedicated consulting team of experienced experts in research, nonclinical and clinical development, GMP manufacture, Quality Assurance and Regulatory Affairs. BioReg Consultancy - founded in 2001 - has gained an excellent reputation among biotech-oriented companies as well as regulatory authorities in Europe and worldwide.

We fulfil your needs ...

by providing customized solutions in the areas of

  • Interim Management Regulatory Affairs
  • Strategic development planning
  • Scientific Advice with Regulatory Authorities
  • CMC development
  • Nonclinical and clinical development
  • Regulatory Affairs hands-on support for dossier compilation and variations
  • Selection of contract manufacturers
  • GxP auditing of contract manufacturers/organisations
  • Quality Assurance
  • Due diligence
  • Trainings/Lectures