Clinical Regulatory Strategy
With a sound strategy, you’ll increase your chances of regulatory approval.
As global regulatory requirements continue to evolve, our expertise helps you stay ahead of the curve. With over 150 regulatory affairs professionals in more than 13 countries, we help you navigate regulatory requirements throughout your product’s development lifecycle.
Our Regulatory Strategy services include:
- 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.