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Biotech Procedures


Products of biotechnological origin must go through the centralised registration procedure at the European Agency for the Evaluation of Medicinal Products (EMEA). They belong to the so-called "List A" products. This leads to an approval (or rejection) for the entire European Union. Hence, planning the right steps, the right authority contacts, and following the right regulatory requirements is the key to success.

We provide our customers with:

  • All relevant and necessary regulatory requirements and guidelines
  • All evolving information from official sources
  • Evaluations on those relevant at a certain point in development
  • Strategies:
    • for an optimal development to obtain a marketing authorisation or
    • to get to proof of concept in man

Our way of working together considers issues like:

  • Marketing partners and strategy
  • Time to first approval and time to market after approval
  • Size of the developing company and size of potential marketing partners
  • Clinical practise in different parts of the EU
  • Health Care and reimbursement systems
  • Authority preferences