Gradient Corp.

Jan. 17, 2007
Service Assists Pharma Manufacturers Navigate EMEA Guidelines

Gradient Corp. has introduced a new client service to assist pharmaceutical manufacturers in their compliance with the new European Medicines Agency (EMEA) environmental assessment guidelines for any new or modified drug application filed after January 1, 2007. Based on a comprehensive review of the EMEA and other global pharmaceutical regulatory requirements, and years of experience assisting clients to comply with earlier versions of the EMEA guidelines, Gradient scientists have developed an innovative and cost-saving approach for designing fate and effects evaluation programs.

Under the new EMEA guidelines, pharmaceutical manufacturers are required to support their drug applications with a series of additional, potentially cumbersome and redundant tests to evaluate the environmental behavior and toxicity of active pharmaceutical ingredients (APIs) in their products. Many of the new tests differ from EMEA's previous protocol, resulting in the obsolescense of API testing work previously accomplished or currently underway.

Gradient has streamlined compliance with the new EMEA regulatory process by combining modeling with strategic test selection, providing EMEA compliance training and developing a free technical bulletin, which identifies the significant changes to the final guidelines and highlights Gradient's cost-effective compliance strategy.

Through its testing and modeling strategy, Gradient can effectively customize individual pharmaceutical assessment programs to ensure compliance with EMEA guidelines while ultimately resulting in potential cost and resource savings to manufacturers.