Pharmatech Associates - A USP Company

ABOUT PHARMATECH ASSOCIATES - A USP COMPANY

Pharmatech Associates is a global consultancy for the life science industry and advises U.S. and global drug sponsors and manufacturers to supply quality medicines in all major markets.

A subsidiary of US Pharmacopeia (USP), 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 bring knowledge across all areas of product development and deep industry experience to every engagement with the goal of reducing time to market for their clients.

Pharmatech Associates’ domain expertise ranges from small molecule to cell and gene therapy, biologics, and advanced manufacturing technologies. Services to clients include regulatory strategy, compliance, and remediation to address manufacturing quality, CMC, and analytical method qualification.

One of Pharmatech Associates’ core strengths is strategic program development. Pharmatech’s team assists clients 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 and business objectives, anticipating FDA’s downstream requirements to reduce program risk.

Pharmatech Associates has earned its reputation as a premier pharmaceutical consulting firm by delivering comprehensive solutions to life sciences organizations including cell and gene therapy, monoclonal antibodies (mAbs), small molecule pharmaceutical innovators, and generic companies. Thanks to its strong commitment to excellence and customer success, Pharmatech Associates empowers clients to address complex challenges in the development of quality medicines.

Learn more at www.pharmatechassociates.com.