CMC Management and Execution
Global regulatory demands on Chemistry, Manufacturing, and Controls (CMC) are intensifying—spanning pharmaceuticals, biologics, and combination products. From tech transfers to lifecycle management, a single misstep in CMC execution can delay approvals, trigger Complete Response Letters, or jeopardize commercialization.
Our integrated, science-driven CMC solutions de-risk filings, accelerate regulatory timelines, and embed quality from R&D through post-approval. Our experts unite Regulatory, Quality & Compliance, Project Management, and Supply Chain disciplines to deliver end-to-end CMC excellence — ensuring your product and processes are audit-ready, globally compliant, and built for scale.
Partner with ProPharma to strengthen your CMC strategy, streamline submissions, and bring your therapies to patients faster — with confidence and control at every stage.
Related Resources
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
Navigating the Generic Drug Application and Approval Process
Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...