CMC & Regulatory Services
Eurofins CDMO network of companies supports a broad range of CMC development activities for Drug Substance and Drug Product, from early stage pre-clinical and clinical studies to registration and long-term commercial manufacture.
We have supported the development, filing, and commercialisation of complex products in numerous regions, including US, EU, Japan, Australia, amongst others, and across a range of file types, from stand-alone DMFs, to dossier content in NDAs or BLAs.
We believe proactive CMC assessment is key to all programs, and we have the capability to provide regulatory perspective from an early point, providing continuity and a ‘one-stop shop’.
Services
- Assisting clients in establishing phase-appropriate strategies, from early to late-stage, commercial development
- CMC gap analysis at milestone stages
- Support of specific CMC topics, such as:
- Designation of cGMP Starting Materials (‘RSMs’)
- Process control development and presentation
- Specification development, for RSMs, raw materials, in-process controls, and API release and stability
- Material characterization
- Impurity risk assessment and control strategy development in line with ICH Q3 and M7 guides, for related substances, reagents, and by-products, including:
- DNA-reactive impurities (genotoxic or mutagenic impurities, ‘GTIs’), including nitrosamines
- Elemental impurities
- Residual solvent and related impurities
- Review, compilation, and authoring of CMC content for a range of file types
- Lifecycle Process Performance Qualification (PPQ, ‘Process Validation’) support, including for process transfers
- General CMC consultancy and support on topics such as Agency meetings, response to Complete Response Letters, and post-approval maintenance
