regulatory cMC

What is regulatory CMC?

Chemistry, Manufacturing and Controls (CMC) documentation of a medicinal product include information on product development, manufacturing process, quality control, stability and more. This is an important and extensive part for all types of medicinal products and applications.


The compilation of CMC related regulatory documentation starts early in development and continue through all stages of the drug development life cycle.


RegFile’s CMC team has in-depth knowledge of the regulatory requirements related to CMC and supports clients ensuring regulatory compliance, product safety and consistency between batches.


Our team works closely with product developers and manufacturers ensuring the development work, processes and controls are documented and presented in a way accepted by authorities.

CMC services

– Gap analysis (due diligence):
Review of your available CMC documentation against ICH/ EU requirements.


– Preparation of agency briefing documents, and support at Scientific Advice meetings


– Technical writing of IMPD and Module 3, summarizing the CMC documentation to be presented to authorities, in line with guidelines, current templates and standards.


– Support with classification and compilation of CMC variations and provision of guidance on what documentation is required, related to a specific change.


– Communication with and coordination of contract manufacturing and development organisations (CMOs/CDOs).


– General CMC advice and guideline interpretation in development and later stages.