QPharma’s Professional Services division specializes in remediation and regulatory compliance consulting. Throughout our more than 20-year history, we have collaborated with numerous FDA-appointed overseers and life sciences client executive leadership to help avoid and/or remediate issues related to warning letters, court-ordered injunctions, product recalls, and other critical events.
For many companies, a strong alignment with a reputable remediation partner is often a vital first step toward restoring the confidence of regulatory agencies, shareholders, consumers, and other stakeholders. QPharma’s flexible, consultative model enables us to provide expertise, resources, and comprehensive project management throughout any phase of a remediation engagement — either by augmenting staff or by planning and executing a major, multi-year project. We also perform quality systems implementation and risk reduction services, including audits, assessments, and mock FDA and regulatory agency inspections.
Lifting of FDA Warning Letter and Prevention of “near-Consent Decree”
In response to FDA action, QPharma was engaged by an external overseer and the CEO of a major pharmaceutical company to form a rapid-response team. QPharma evaluated existing validation documents, prioritized initiatives, and presented risk-based assessments and project plans to the company’s executive management. QPharma provided on-site support in two states, developing and executing against seven category-specific Validation Master Plans and overseeing the entire remediation and validation program — from planning, to execution of protocols, to preparation of final reports. As a result, the warning letter was satisfied and FDA elected not to pursue further action.
Prevention of Impending Warning Letter
QPharma was engaged by the executive management of a pharmaceutical company that had been acquired by another company and been notified of an upcoming FDA inspection. The facility had not been inspected in more than 20 years, and a warning letter was anticipated. QPharma formed and co-chaired a Validation Steering Committee and oversaw a program that included the validation of nearly 20 manufacturing lines covering hundreds of products. QPharma was able to validate the most critical lines within six months and the entire facility within 18 months, resulting in a successful FDA audit.
These are just two of numerous examples of numerous large-scale remediation engagements in which QPharma has been involved — and additional projects are under way, including one for a major global medical device manufacturer.
To learn more about why QPharma is the ideal remediation consulting partner, please contact us.