Success Stories

  • We successfully helped clear an FDA Warning Letter with a major Large Volume Parenterals site. Our contribution involved conducting a systemic walk-through of over 1200 Standard Operating Procedures with the site’s subject matter experts, and completely revamping all the procedures. This resulted in a fully integrated Quality Management System and won FDA’s acceptance.

  • We successfully trained and qualified over 60 professionals across five different sites in India on “Conducting Effective Investigations”.

  • We conducted over 100 quality and compliance audits for various clients to successfully meet the requirements of their Quality Management System.

  • We successfully re-established the entire Quality Management System for a large generic pharmaceuticals company in Canada.

To write your own success story,  and to get a free quote, please contact us today.

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