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

• 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)
• Innovative Licensing and Access Pathway (UK) and PRIME (EMA) submissions