Pharma CMC & Inspection Readiness
FDA's review of a drug or biologic rests on two things that rarely get equal attention: the CMC (Chemistry, Manufacturing, and Controls) data filed in Module 3 of the submission, and the facility inspection that verifies it. A strong CMC package does not guarantee a clean Pre-Approval Inspection, and a compliant facility does not automatically produce a submission-ready dossier. We work both sides of that gap, drawing on direct CDER experience in quality policy, CMC review, and international GMP inspections.
- CMC strategy and dossier preparation
Drug substance and drug product data, manufacturing process description, specifications, control strategy, and stability data, prepared to the standard expected in Module 3 of the eCTD for INDs, NDAs, ANDAs, and BLAs.
- IND, NDA, ANDA, and BLA submission support
CMC sections for Investigational New Drug applications, New Drug Applications, Abbreviated New Drug Applications, and Biologics License Applications, built from direct experience reviewing these same sections at CDER.
- Pre-Approval Inspection (PAI) readiness
FDA ties PAIs directly to a pending application, and the inspection team checks whether the facility and process match what was filed. We align the CMC data and the manufacturing site before FDA arrives, not after a deficiency.
- GMP surveillance inspection support
Routine, risk-based CGMP surveillance inspections under 21 CFR Parts 210 and 211, including mock inspection preparation, front-room and back-room support during the inspection, and post-inspection strategy.
- Form FDA 483 and Warning Letter response
A Form 483 typically allows 15 business days for a voluntary written response. We build observation-by-observation responses with root cause analysis and CAPA planning that reflect how FDA actually evaluates a response, not just what reads well on paper.
- Post-approval CMC changes and annual reporting
Categorizing manufacturing and facility changes as major, moderate, or minor under FDA's post-approval change guidance, and preparing the supplements or annual report documentation each category requires.
- Foreign inspection and multi-site coordination
For sponsors manufacturing outside the U.S., coordinating CMC documentation and inspection readiness across multiple facilities and geographies, informed by direct experience conducting foreign drug inspections for FDA.