The scope of Hurley Consulting’s ISO 9001:2000 certification states:

Hurley Consulting Associates Ltd. provides pharmaceutical consulting services, including study design, medical writing, data management, QA functions (including product release), preparation of submissions to FDA and other regulatory authorities. The company acts as U.S. agent and authorized representative for regulated products for the entire IND through NDA process and post-approval regulatory matters including regulatory strategy, FDA negotiations, submissions and application approvals.

ISO certification is an internationally recognized standard for quality assurance in any industry. Recommendation for ISO certification and achievement of registration affirm that Hurley Consulting’s quality systems are well above the bar for outsource services.

"The pharmaceutical industry is a highly regulated industry with demanding requirements for each stage of the drug approval process and differing regulations among nations. Hurley Consulting has long asserted that its standards and procedures were above industry requirements. Certification of compliance with the ISO 9001:2000 standard is external validation of Hurley Consulting’s quality procedures and processes performed by qualified personnel," said Margaret E. Hurley, M.D., President and Chief Executive Officer, Hurley Consulting Associates Ltd.

In its first attempt in 1999, Hurley Consulting achieved certification to the predecessor (ISO 9002:1994) of the ISO 9001:2000 standard by an independent ISO registrar SGS International Certification Services. In 2002, Hurley Consulting again has demonstrated that its high operational and quality standards meet the rigorous requirements of the new ISO 9001:2000 standard.

The ISO certification process was originally designed to certify the quality standards of manufacturers. Therefore, it is impressive that a consulting firm, whose chief output is intellectual property and documents, was well prepared to meet the ISO 9002:1994 quality standard and now meets the process-emphasized new ISO 9001:2000 standard.

Founded in 1987, Hurley Consulting Associates Ltd. employs over fifty individuals including pharmacologists, pharmacokineticists, toxicologists, physicians, regulatory specialists, statisticians, computer programmers, clinical research associates, analytical chemists, medical writers, editors, and data analysts.