CMC Regulatory Affairs
From early development to commercial manufacturing, Boyds’ CMC specialists ensure your chemistry, manufacturing, and controls meet global regulatory expectations.
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.
WHY BOYDS?
Deep CMC expertise.
Proven regulatory success.
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.
- Specialist CMC regulatory experts with agency experience
- Proven success across biologics, ATMPs, small molecules and medical devices
- Strategic tailored solutions from early development to lifecycle management
- Collaborative, responsive and flexible support
OUR CMC SERVICES
Comprehensive CMC regulatory support
Module 2.3, 3 & IMPD Authoring
Preparation of high-quality CMC documentation to support IND, CTA, BLA, NDA and MAA submissions.
Agency Response Support
Authoring scientifically robust responses to regulatory agency questions throughout review.
CMC Document Review
Critical review of source reports, Module 3 documentation and supporting regulatory data.
CMC Gap Analysis
Identify regulatory gaps early and provide practical recommendations before submission.
Agency Meeting Strategy
Strategic preparation for FDA, EMA and MHRA meetings, briefing packages and regulatory interactions.
Lifecycle & Manufacturing Support
Support for shelf-life justification, specification strategy and post-approval manufacturing changes.
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.
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.