Product & Process Development

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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 TROUBLE-SHOOTING

ACQUISITION/PARTNERING DUE DILIGENCE

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Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

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22320 Foothill Blvd. Suite 330, Hayward CA 94541