Global Drug Development Consulting
Translating innovative science into new treatments for patient benefit
Drug development support to expedite the route to market for new medical products and devices.
With offices in the US, UK and Europe, Boyds’ provides expert drug development consulting services central to the development of pharmaceutical and biotechnology products and medical devices. Our geographic span accommodates single or multiple-country filing strategies and leverages our well-developed relationships with the respective health authorities.
Working with early-stage projects from pharma companies of all sizes, biotechs, medical device companies and universities, the Boyds team specializes in gene & cell therapies, orphan drugs, small molecules and biologics across a range of therapeutic areas and technologies.
The team has expertise in programme management and product development, clinical operations, medical monitoring, regulatory affairs and strategy, medical writing and provides scientific and medical advice to help translate ideas into medicinal products.
We understand that no two projects (or products) are the same, which is why we work with our clients as part of their team to offer a bespoke and tailored service that will help achieve project milestones and accelerate marketing approval.
Our focus is on making difficult things possible, solving problems and finding solutions while maintaining superior client satisfaction and contributing to advances in modern medicine.
Looking to file in the US?
Looking to file in the UK or Europe?
The Code of Federal Regulations, specifically 21 CFR § 207.69, requires all domestic and foreign companies to have an official contact located in the US in order to act as the primary contact with the FDA and liaise between the FDA and the sponsor company for all communications. Specifically for non-US (foreign) entities, any company that wishes to register a new medicine or device with the FDA must appoint a US agent, as must foreign companies that wish to import medicines during the registration process. Boyds can act as a trusted US agent to engage the FDA for all inquiries, meeting requests and scheduling, facilitation and compilation of submissions, as well as emergency notifications.