Pharmatech Associates, a USP company

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Pharmatech Associates, a global consultancy for the life science industry, advises U.S. and global drug sponsors and manufacturers of quality medicines in many major markets. A wholly owned subsidiary of U.S. Pharmacopeia (USP) with expertise in small molecule, cell & gene therapy, biologics –monoclonal antibodies– and advanced manufacturing technologies. Services include product and process development, quality management, quality assurance, and product management. Pharmatech Associates helps clients navigate the regulatory landscape of the FDA and international health authorities and provides guidance for U.S. market entry. Pharmatech Associates serves clients ranging from start-ups to large multi-national corporations. The company's multidisciplinary team of professionals are thought leaders with integrated knowledge across all areas of product development who bring industry experience to every engagement reducing time-to-market for their clients. One of Pharmatech Associates' core strengths lies in strategic program development. Pharmatech's team assists clients in navigating the regulatory landscape of FDA and international health authorities, helping them achieve and maintain compliance. This expertise is vital to success during product development, manufacturing, and commercialization phases, ensuring that clients meet stringent regulatory requirements while meeting business objectives and anticipating FDAs downstream requirements to reduce program risk. Pharmatech Associates guides clients by helping organizations implement robust quality management systems, conduct risk assessments, investigate deviations through thorough root cause analysis, determine CAPAs, and provide training to build competency and ensure compliance with industry standards.

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product & process development, regulatory affairs, regulatory compliance, filing, publishing support, chemistry manufacturing controls, 510k, pre approval inspection, fda design controls, quality managment systems, quality risk management, compliance remediation, operational excellence, tech transfer, analytic methods & validation, facility design, process optimization, cell & gene therapy, mabs

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