- 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.