PRODUCT AND PROCESS DEVELOPMENT
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.
Pharmatech led the industry by developing the first Lean Six Sigma approach to program design and deployment for the regulated life science markets. With deep insight gathered from decades of experience in Chemistry, Manufacturing and Controls (CMC), Pharmatech will guide you in implementing an efficient and effective program to take your product from inception to development and through the regulatory process. Using proven methodologies, Pharmatech will ensure that your process is defensible, predictable, and applicable to even areas like cleaning validation. In addition to supporting the regulatory and compliance process, our leadership and End-to-End technical expertise is sought after for due diligence evaluations for private equity investor communities.
CHEMISTRY/ MANUFACTURING/ CONTROLS (CMC)
OPERATIONAL EXCELENCE, INCLUDING TRAINING, CERTIFICATION AND DEPLOYMENT
TECH TRANSFER, PROCESS SCALE UP AND
ACQUISITION/PARTNERING DUE DILIGENCE