Chemistry, Manufacturing & Controls (CMC)

 V2 supports CMC strategy and execution across early development through commercial readiness. Our team brings deep experience in process development, analytical methods, specifications, stability planning, comparability, technology transfer, and CMC sections for INDs/CTAs/NDA/BLA filings.

We help sponsors build the right CMC narrative, avoid common regulatory pitfalls, and maintain alignment between manufacturing sites, CDMOs, and regulatory requirements. 

Services include:

• CMC strategy for small molecules, biologics, cell/gene therapies, and novel modalities 
• CMC writing: Module 2 & Module 3 
• CMC QA oversight and audit readiness 
• CDMO selection, oversight, and performance management 
• Gap assessments for IND/IMPD readiness 
• Analytical method development & qualification support 
• Stability protocol design and data review 
• Tech transfer coordination and documentation review 

Our focus is pragmatic: clear expectations, inspection-ready documentation, and operational rigor that protects your timelines and regulatory path.