Quality and regulatory

We have a disciplined approach to Quality in all aspects of our business

Our customers expect to receive a quality product and the consumers that use the products we supply trust that they are safe and effective. Each of our employees at PL Developments is a quality stakeholder in the manufacturing and packaging of all the products that we supply to the marketplace. We have implemented the ICH (International Conference on Harmonization) Guidance’s Q8, Q9, and Q10 covering drug product development through Quality by Design, Risk Management, and Quality Management Systems. This ICH guidance is aligned with the FDA’s Critical Path Initiative, Moving Manufacturing into the 21st Century, to develop new manufacturing approaches that improve pharmaceutical manufacturers’ ability to assess and improve product quality. Our highly trained team develops and validates laboratory methodologies, monitors ongoing stability, and supports the formulation and manufacturing process from development through commercialization.