Strategic scientific and regulatory support for drug development projects

Through our links with organisations such as the Association for Human Pharmacology in the Pharmaceutical Industry www.ahppi.org.uk and the European Federation for Exploratory Medicines Development www.eufemed.eu, our experts in regulatory affairs have established firm relationships with the regulatory agencies in the UK, US and EU. The company’s longevity and involvement in many innovative projects over the last 25+ years have served to build an unrivalled body of experience that can be deployed in helping you engage in informed and productive discussions with regulatory agencies.

Our team are eager to help you with the regulatory affairs support you need to facilitate the fast and efficient development of your innovative medicines. Comfortable integrating with your scientific leaders, the Niche team is highly flexible and can adapt to your needs, whether that involves us playing a lead regulatory lead role or simply assisting your existing regulatory team via the provision of thoughtful and well-considered strategic input. In addition to supporting your cutting-edge and advanced therapies along their regulatory journey, the Niche team have access to the necessary resources to assist with the preparation of regulatory documentation in a timely fashion, guiding you past the various milestones that mark your product’s journey from the laboratory to the market.

Regulatory process support, including:

• Regulatory strategy
• Due diligence and gap analysis
• Regulatory strategy for paediatric development
• Lifecycle management (EMA, MHRA, FDA)

Development of clinical/non-clinical regulatory submissions:

• CMC, non-clinical and clinical expertise
• Clinical trial applications (EMA, MHRA, FDA)
• Orphan drug applications (EMA, MHRA, FDA)
• Scientific advice (EMA, MHRA, FDA)
• Marketing authorization applications (EMA, MHRA, FDA)
• The Innovative Licensing and Access Pathway (UK) and PRIME (EMA)