Regulatory Strategy services

  • Consultation/ Development of Regulatory strategy to support country-specific or worldwide registration
  • Guidance and advice for optimized testing packages of nonclinical and clinical studies consistent with your vision and the applicable regulatory requirements.
  • Target Product Profile (TPP) and Clinical Development Plan (CDP) preparation or review and critique
  • Regulatory / industry intelligence using internal and external information
  • Independent due diligence/ scientific review and gap analysis of study data (CMC, nonclinical, clinical)
  • Specific services (for example, pediatric plan development, orphan drug designation, abuse liability potential or advanced medicinal therapy designation support)
  • Agency interactions – input into questions and Background Information briefing document, and support for agency meeting.
  • Expertise in the assessment of abuse potential of CNS active compounds.
  • Expertise in the development of rare diseases, biosimilars, tobacco, NASH, cardiovascular, diabetes, infectious disease, rheumatology/immunology and oncology products.
  • Coverage of small molecules, biological drugs and gene/cell therapy products.


Full Service or Project Based

It starts with Our customers’ requirements

Customers’ requirements vary, from full-service support to very specific project work.  In each situation, our Project Managers and Programming Staff complete the mission.