Woodley BioReg delivered successful scientific advice to accelerate biosimilars development and the registration of a biological product.

Our client was based in the EU and was seeking to develop a biosimilar to an existing product approved in the US. As a relatively new entrant to the biosimilars sector, the client was capable of manufacturing the product and demonstrating batch-to-batch consistency, but had limited experience and exposure to the US regulatory framework for the development of biosmilars.

Woodley BioReg was approached to help define the process and activities to enable product development in the US. Our team identified a number of clinical and CMC areas that would require input and regulatory agreement as part of de-risking the development of the client’s biosimilar.

We led the development of the Type C meeting Briefing Book, including refining the client’s questions and defining the Applicant’s position. We also led the meeting with FDA and ensured all follow-up actions and activities were completed and reported.

Following the Type C meeting, Woodley BioReg has continued to support the client through scientific advice meetings with EMA and MHRA, and is now in the process of completing the clinical studies and simultaneously preparing the marketing authorisation application.

 

Advice and guidance that you can trust, no matter the complexity of your project or product

We only work with the very best time-served consultants; those with many years of industry or agency experience. We offer the highest quality technical knowledge at every stage — even on the most complex and niche projects — and are able to help you develop regulatory and quality strategies that ensure your success.

No matter how much or how little support you need, whether that’s flexible resourcing from the preclinical / nonclinical stage right through to Product Licence or certification maintenance, or if you just need light help at any step in between, you can be confident that Woodley BioReg will be there.

 

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With extensive experience and a successful track record in all aspects of regulatory affairs.

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Consultants that are up to speed on the constantly shifting regulatory and quality landscape.

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Extensive industry knowledge

No project is too complex — our consultants will be able to offer advice and support.

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From “man in the plant” services to an extra pair of helping hands on a project, we’re here.

Best-in-class scientific advice

In regulatory affairs, clinical/nonclinical, and project management at all stages of product development.

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Tom Coates

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