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CMC Regulatory Affairs

From early development to commercial manufacturing, Boyds’ CMC specialists ensure your chemistry, manufacturing, and controls meet global regulatory expectations.

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Regulatory affairs
The Chemistry, Manufacturing, and Controls (CMC) component of a regulatory submission demonstrates that your product can be consistently manufactured to the right quality standards.

Boyds provides strategic CMC regulatory affairs support for early development, clinical, and marketing submissions – helping you design, document, and defend your approach across the product lifecycle.

With extensive technical, operational, and strategic expertise, Boyds provides trusted support in CMC regulatory affairs.

We have a proven track record in delivering high-quality CMC documentation to support every phase of development across a wide range of therapeutics — including small molecules, biologics, and cell and gene therapy products such as cell therapy, in vivo and ex vivo gene therapy, and tissue-engineered products.

Our CMC services include:

  • Preparation of clear and concise documentation (module 2.3, module 3, IMPD) to facilitate review of the IND/CTA//BLA/NDA/MAA
  • Authoring responses to agency questions
  • Critical review of source reports and regulatory documentation
  • Gap analyses
  • Agency meeting strategy and preparation
  • Strategic support for shelf-life setting, specification review, and managing manufacturing changes
Speak to our CMC experts

Proven success across complex CMC submissions

Our team has supported regulatory submissions across biologics, gene therapies, and novel excipients — helping clients achieve faster, smoother approvals.

  • Leading EMA scientific advice meetings for pluripotent-derived, tissue-engineered products, guiding clients through complex regulatory interactions.
  • Authoring Module 3 documentation to support successful marketing applications for ex vivo gene therapy products.
  • Conducting comprehensive gap analyses and authoring IMPD/Module 3 documentation, including preparation of responses to agency questions for CTA and IND applications across multiple in vivo gene therapy programs.
  • Preparing IMPDs for monoclonal antibodies, achieving zero agency questions during review.
  • Developing and submitting FDA CMC Development and Readiness Pilot (CDRP) Program applications for new chemical entities, resulting in successful acceptance.
  • Leading cross-functional collaboration to prepare GMO environmental risk assessments, define impurity acceptance criteria, and develop robust scientific justifications for novel excipients — ensuring alignment with EMA and FDA expectations.

What our clients say

We’re proud to support biotech and pharmaceutical companies around the world with expert CMC regulatory affairs guidance. Here’s what some of our clients say about working with Boyds.

“We really value the regulatory advice and support that Boyds provides to ***** because it ensures that our development plans are efficient and compliant. In addition, we specifically value the CMC expertise that Boyds brings into the preparation of our IMPD. Lastly, we are grateful for the flexibility that the Boyds team provides on an ongoing basis which is of great benefit to us.”
~ UK-based Biotech Company
Boyds represents excellent value compared to other providers because the work is done right the first time. For example, during the ****** Phase 1 study, I expected MHRA questions on the CTA due to complex CMC documentation — but none arose, thanks to Boyds’ expertise in preparing the IMPD. Their high-quality work ultimately saved significant time and costs by avoiding trial delays.
~ UK-based Biotech Company
Our award-winning regulatory team provide CMC regulatory affairs support at every stage of development.

Get in touch

If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.