Regulatory Planning and Execution is vital to every pharmaceutical product, and we have long-term experience and broad resources in negotiating with the Regulatory Agencies.

Whether provided as part of overall program management or on a stand alone basis, we advise on the full range of regulatory projects including:

  • Filing and Negotiation for Pharmaceuticals, Medical Devices, Combination Therapies
  • Target Product Profile, Clinical Development Plan, Risk Management Plan.
  • Study Design and Protocol Development
  • Orphan product designations
  • Regulatory Guidance
  • Advice on global regulatory requirements
  • Safety Review in Clinical Research and Post-Marketing
  • Adverse event report collection & processing
  • Adjudication Committee – DSMB establishment & management
  • Representation of clients or participation at Regulatory Agency meetings
  • Responses to agency questions and appeals