Quality and Regulatory

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

Our customers expect quality products and the end-consumer trusts that they are safe and effective. Each employee 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) Q8, Q9, and Q10 Guidances 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. This will improve the 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.