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:

  • Identify opportunities and issues
  • Planning, preparation and application of Scientific Advice meetings (Europe and FDA)
  • 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

 We provide:

  • Regulatory review in relation to eg investment decision
  • Due diligence activities
  • 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