Orphan Drugs

OUR TEAM CAN PREPARE REGULATORY DOCUMENTATION, PROVIDE POST-APPROVAL SUPPORT, AND OFFER EXPERT ADVICE FOR YOUR ORPHAN DRUG DEVELOPMENT.

- Dr. Christiane Chène Senior Scientific Expert, Medical and Pre-clinical Services

Orphan Drugs

The Orphan Drug Designation (ODD), a legislative and regulatory framework, provides a number of incentives supporting companies developing drugs for rare diseases. This framework has been adopted by a number of countries and regions, including the EU, US, and Japan. Although there are similarities among these regions, criteria and procedures vary.

We can support you with:

Application for ODD in the EU, US, and Japan

  • Strategic advice
  • Scientific documentation
  • Procedural steps
  • Pre-submission meetings (where applicable)
  • Follow up as needed

Activities after ODD

  • Annual reports
  • Scientific advice (protocol assistance)
  • Best use of incentives


Have a question concerning Orphan Drugs? Contact Dr. Christiane Chène.