Experts in navigating the UK and EU regulatory landscape.
Boyds has significant experience in successful interactions with the EMA’s CHMP, EU national agencies, and the UK’s MHRA for cutting-edge medicinal treatments and technologies.
We work closely with our clients to understand and advise on regulatory strategy for interactions at all stages of drug development.
Boyds is uniquely positioned to help US pharma companies, academic groups and biotechs approach different markets and to leverage agency feedback accordingly.
We evaluate and propose appropriate topics for discussion at each stage of development, draft relevant and precisely worded questions, prepare briefing packages, and then represent our clients at the agency meetings to ensure the company’s objectives are met.
We assign a single regulatory project lead to each project with an understanding of the therapeutic area and/or product type to work with you throughout the process. Additional experts are available in our network to contribute if specific technical strategy is required. Our established, strong and open working relationships with target agencies mean that we can professionally and productively support you on your journey, bringing the knowledge and understanding of the regulators’ views gained via our multiple interactions across countries.
With offices in the US, EU and UK, Boyds is able to work effectively in the same time zone as the target regulatory agencies and we are able to make contact with agencies on your behalf to resolve procedural queries in real-time. In addition, Boyds has SME status with the EMA and we are able to offer, for companies that qualify based on the EMA’s SME criteria, access to the incentives for SMEs in the EU, including fee reductions for scientific advice from the CHMP.