Regulatory Services for Cell & Gene Therapies
Our experts have supported 11 of the approved cell and gene therapy products available on the market today.
Book a free introductory call with an expert.
To discuss how Boyds can support your cell & gene therapy projects, complete this form and book in a free introductory call with one of our experts.
Boyds was established by Professor Alan Boyd, a pioneer in cell and gene therapy. Boyds has a long track record in strategic drug development for new innovative therapeutic approaches and is committed to shepherding products through regulatory pathways. Our key staff have over 15 years of working across a broad range of C> in the US and EU and have supported 9 of the approved C> products on the market today.
Regulatory Plans – Strategies tailored to your program needs
Regulatory CMC Experience – In vivo & ex vivo gene therapies, somatic cell therapies & pluripotent-derived cell products
Science & Technical Expertise – Regulatory expertise to support the development of innovative therapies
Regulatory Affairs & Operations – Informed, productive discussions with global regulatory agencies
Global Regulatory Expertise – Interactions with the FDA, EMA & national agencies in Europe (PEI, MPA, MHRA)
Regulatory & Medical Writing – Well-written, accurate and polished documents that meet all the regulatory requirements
Document Publishing – In-house publishing services to optimize and streamline the submission process
In addition to the above, Boyds has extensive regulatory experience and expertise in NCE and biologic products as well.
