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.
Orphan drug designation
Boyds has long-standing experience in obtaining orphan drug designation (ODD) across multiple product types and can act as the sponsor for ODD applications on behalf of our clients. We can prepare and submit initial applications and annual reports to the designation.
EU & UK Legal Rep
Boyds legally established EU and UK entities enables us to act as EU or UK legal representative for a single clinical trial or an entire clinical program in accordance with Article 19 of EU Directive 2001/20/EC, Article 74 of Regulation 536/2014, and the UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), supporting ex-EU/UK companies to initiate or complete clinical development in the EEA/UK. This role can be undertaken in conjunction with Boyds’ clinical operations, regulatory or medical affairs services. As part of this service, Boyds also ensures sponsors are kept up to date with the latest EU legislation.
SME status from the EMA
Boyds has micro, small and medium-sized enterprise (SME) status with the European Medicines Agency (EMA). If you are an ex-EU company and meet the SME criteria (<250 employees and either an annual turnover of <€50 million or an annual balance-sheet total of <€43 million), contact us to see how we can help you obtain access to the available SME incentives, which currently include reduced fees for scientific advice, inspections and marketing authorisations via the EMA and administrative support from EMA staff.
Find out how Boyds can help you on your drug development journey.
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