PRODUCT AND PROCESS DEVELOPMENT

For all Life Science product programs, from early stage development through manufacturing scale-up and commercialization, Pharmartech’s Product and Process Development frameworks will establish your products requirements and ensure they are clearly defined and well understood while minimizing compliance and regulatory risks.

 

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 and predictable. 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  

 

Services-Product