Pharmatech’s Product and Process Development frameworks will define your products’ requirements, establish a repeatable product development process, and ensure they are clearly defined and well understood. The framework minimizes compliance and regulatory risks for all Life Science product programs, from early-stage development to technology transfer through manufacturing scale-up and commercialization.

• Chemistry/Manufacturing/Controls (CMC)
• Regulatory Application Preparation (NDA, BLA, MAA, ANDA, PMA, 510K
• Quality by Design (QbD)
• Specification Justification
• Operational Excellence, including training, certification, and deployment
• Tech Transfer, Process Scale Up and trouble-shooting
• Process Development
• Facility Design
• Acquisition/Partnering Due Diligence

Pharmatech Associates has the expertise to guide you through the product development process. Contact us today for advice.