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Stem Cell Research
Pharmatech Associates' Consulting Services division focuses on the broader strategic and tactical issues relating to the huge time and capital requirements associated with development and manufacturing facilities. Thanks to our proven methodology that takes into account existing systems as well as business objectives, Pharmatech Associates works with its customers to rapidly identify opportunities to improve quality control systems and processes, and takes charge of their implementation. Our extensive network of contacts throughout the pharmaceutical, bio-pharmaceutical and medical device/diagnostics industry means we leverage the lessons learned from industry leaders and tailor them to meet the needs of start-up and mid-size organizations. Further, our commitment to extend beyond simply recommending solutions to participating in their implementation distinguishes us from many consulting organizations in the sector. Pharmatech's strong experience in all elements of Chemistry, Manufacturing and Controls (CMC) phases allows us to assist clients in early feasibility and Proof-of-Concept (POC) investigations, including experimental designs for process characterization and product scale-up, development report preparation, establishment of clinical manufacturing operations and quality systems, implementing validated facilities and manufacturing systems and preparing clients for successful Pre-Approval Inspections (PAI). We work with our clients to develop increased plant capacity, improve productivity and process yields and eliminate waste through the application of Lean Six Sigma methodologies, and have realized gains of 40-50% in increased capacity with each project. Pharmatech Consulting Services focus on cGMP readiness, quality systems and GMP/QSR compliance, Warning Letter/regulatory action response planning, facility site selection and design, process excellence program deployment (Six Sigma and Lean), product in-licensing and technical training.
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