Achieve Cell & Gene Therapy Regulatory Success with Pharmatech Associates

The product is often the process. With living materials, small batch sizes, and limited characterization tools, you can’t rely on end-product testing the way you can with other processes. Control strategy, comparability, and potency assays carry far more weight, which means it’s even more important to have all three built into your CMC strategy from the beginning.

Earlier than most teams expect. Decisions made in early clinical development—raw material sourcing, analytical methods, process design—become comparability problems at BLA stage if they weren’t made with commercial scale in mind. We help you make those decisions once.

We build comparability protocols before the change, not after. That means defining the analytical package, acceptance criteria, and regulatory strategy up front so a necessary process improvement doesn’t cost you a clinical hold or a bridging study you didn’t budget for.

Yes. Accelerated designations compress your CMC timeline without reducing expectations. We help you build the manufacturing and quality package to match the pace of your clinical program, so CMC readiness doesn’t become the reason your approval slips.

It means building the infrastructure your program needs at its current stage, then expanding it as you advance. A pre-clinical company shouldn’t carry commercial QMS overhead—but it also shouldn’t build something it has to tear down at Phase 3. We right-size the system and scale it with you.

We approach it as a patient safety issue first and a documentation issue second. We help you design and validate the controls, labeling, and tracking systems that prevent misassignment across collection, manufacturing, and infusion—and document them in a way that stands up to inspection.

Yes. We support programs across the US, EU, Canada, Mexico, and Japan, including multi-market facility design review and submissions. Advanced therapy medicinal product expectations in the EU don’t map one-to-one to FDA expectations, and we help you plan for both rather than sequentially.

Yes. We manage technology and analytical method transfer end to end—risk assessments, protocols, batch records, SOPs, and training—and maintain regulatory alignment throughout so the transfer doesn’t create a comparability or filing problem.

Commissioning, qualification, and validation covers design and submittal review, factory and site acceptance testing, qualification protocol execution, and the document approval process behind all of it. For CGT sites, aseptic design, segregation, and contamination control get particular attention.

Yes. We conduct mock inspections structured around what agencies actually prioritize in advanced therapy manufacturing, pressure-test your investigations and documentation, and close gaps before an inspector finds them.

We’re built to move fast. In many cases, we can begin within days—and you can be on a call with a subject matter expert within hours of connecting with us.