NGT recognizes the critical importance of quality and compliance, especially in the highly regulated biopharmaceutical industry. Our expert consultants work collaboratively with our clients to ensure GxP compliance, from preclinical through clinical development and beyond to commercialization and life-cycle management. NGT services include the following:
CASE STUDY – Quality Management System Design & Implementation
A start-up pharmaceutical company with a promising pre-clinical development drug candidate wanted to utilize an existing non-GMP facility to manufacture clinical, and potentially commercial, supplies of the compound.
An extensive evaluation of the company’s existing facility, processes and procedures was conducted. To ensure compliance with current Good Manufacturing Practices (cGMP), a fully cGMP compliant Quality Management System (QMS) was designed and implemented for the existing facility.
Implementation of the QMS system ensured that the existing facility was cGMP compliant for both clinical and commercial drug manufacturing. With a cGMP compliant facility, the client could proceed to manufacture their promising drug candidate for clinical development. Overall, converting the existing facility to a cGMP compliant facility resulted in substantial cost savings and an accelerated clinical development timeline.