Strategic Regulatory Support
The award winning team has long-standing, trusted relationships with the regulatory agencies in the UK, the US and Europe.
Get in touch to find out how we can help you with the regulatory affairs support needed to facilitate the fast and efficient development of your medicinal product ➡️
The Regulatory team at Boyds is highly experienced in working with cutting-edge and advanced therapies and is able to innovate successfully when faced with novel situations for which there may be no precedent. We work closely with you to develop the regulatory strategy needed, preparing and submitting the regulatory documentation, helping to guide you through the various regulatory procedures to bring your product to market quickly and efficiently.
Regulatory affairs services:
- 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)
- Regulatory strategy for paediatric development
- Environmental risk assessments
- Marketing authorisation applications (EU, US)
- Lifecycle management (EU, US)
Looking to file in the US?
Looking to file in the UK or Europe?
Speak to our award-winning regulatory team today.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.
