Overview

Pharmatech Associates is a global consultancy for the life science industry and advises U.S. and globally-based drug sponsors and manufacturers in all major markets to supply quality medicines. As a wholly owned subsidiary of US Pharmacopeia (USP) with domain expertise from small molecule to cell and gene therapy, biologics, and advanced manufacturing technologies, services include regulatory strategy, compliance, and remediation, CMC, process, equipment and facility development, analytical method qualification and advanced manufacturing strategy and planning. We advise clients from start-ups to large multi-national corporations from our headquarters in San Francisco, California. Pharmatech Associates is an established trusted partner for organizations seeking product and process development, quality management, quality assurance, project management, US market entry, and validation expertise. 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.