CMC Regulatory Affairs
The Boyds team has extensive experience providing technical, operational and strategic support for regulatory CMC.
We have a proven track record with delivery of high-quality CMC documentation to support all phases of development across different classes of therapeutics including small chemical entities, biological and cell and gene therapy products (including cell therapy, in vivo and ex vivo gene therapy and tissue engineered products).
We help our clients with a range of tasks including:
- 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 preparation.
- Strategic support for issues such as shelf-life setting, review of specifications and introduction of manufacturing changes.
Examples of CMC regulatory support include the following:
- Leading an EMA advice meeting for a pluripotent derived tissue engineered product.
- Authoring of module 3 documents to support a marketing application for an ex-vivo gene therapy product.
- Gap analyses, IMPD/module 3 authoring and response to agency questions for CTA and IND applications for multiple in vivo gene therapy products.
- Authoring of an IMPD for a monoclonal antibody and receiving no agency questions.
- Preparation of a successful application for the FDA’s CMC Development and Readiness Pilot (CDRP) Program for a new chemical entity.
- Working cross-functionally to prepare GMO environmental risk assessments and write justifications for impurity acceptance criterion and acceptability of novel excipients.
