Regulatory Affairs Services
Boyds has an enviable team of experts with long-standing, trusted relationships with the regulatory bodies. The reputation held by the team, due to its depth of experience, means Boyds is able to engage in informed, productive discussions with the regulatory bodies.
This unique position helps us to help you with the regulatory affairs support needed to facilitate the fast and efficient development of medicinal products.
The team is highly flexible and can work with clients in a way that suits the client’s needs, whether as a regulatory lead role in the project team, or simply to assist your existing regulatory staff as required with thoughtful and well-researched strategic input.
Boyds’ experience with advanced therapies is extensive and we are able to innovate successfully when faced with novel situations for which there may be no obvious precedent. As well as strategic input, Boyds can assist with the preparation of regulatory documentation to support our clients’ activities, and guide them through the various procedures to bring their product to market.
- Regulatory strategy
- Due diligence and gap analysis
- CMC, non-clinical and clinical expertise
- Clinical trial applications (EU, US)
- Orphan drug applications (EU, US)
- Scientific advice (EU, US)
- Paediatric investigation plans
- Environmental risk assessments
- Marketing authorisation applications (EU, US)
- Lifecycle management (EU, US)