We provide scientifically based strategic and operational support and advice to companies and academia from early research throughout the product lifecycle.
As part of your project team, we will analyse the regulatory environment and precedence, scientific basis and current regulatory thinking. We assess preclinical, clinical and CMC data and development plans from a regulatory perspective; identifying opportunities and issues and providing a regulatory strategy moving forward. Our services may include:
- Support development of Target Product Profile (TPP)
- Building an integrated regulatory and clinical plan, the central part of the overall development plan to support EU and US approval.
- Identify opportunities, challenges and risks. Develop mitigation strategies. Planning, preparation and application of Scientific Advice meetings (Europe and FDA)
- Planning, preparation, and application of US IND
- Orphan drug strategy and application
- Paediatric investigational strategy and application
- Advice on potential use of regulatory tools and pathways, e.g PRIME (EU) and Breakthrough Designation (US)
- Recommendation on regulatory procedures and legal basis
- Time and cost estimates associated with the clinical development plan.
- Regulatory and clinical development review in relation to e.g. investment decisions.
- Due diligence activities
- Small and medium-sized enterprise (SME)-status, information about benefits and qualification requirements
We provide scientific drug development expertise in:
- Pharmaceutical development, selection of dosage form and formulation
- Clinical pharmacology, pharmacokinetics, and drug interaction
- Clinical plans PhI – PhIV including study design concept development.
- Project management