Case studiesQuality Assurance
BioPoint understands how important it is to your company that your quality systems work efficiently and comply with the current domestic and international regulatory requirements. As the regulatory landscape around clinical development evolves, it is vital for our clients to meet regulatory expectations and still remain competitive in the marketplace.
Implementation of a QMS System & FSP Consulting Support
Our client was preparing for an EMA certification of their manufacturing process to begin manufacturing materials for distribution to, and use in, the EU. Part of that preparation included updating their Quality Management System (QMS) as well as developing and implementing a GMP readiness program to ensure compliance with EU manufacturing standards. The current QMS was paper-based and they intended to make the transition to automate.
Senior leadership at the client required a flexible yet highly specialized partner to act as a Functional Service Provider. It was essential that this partner be able to meet evolving project deliverables, quickly assemble the necessary resources and integrate them either with their team or as standalone experts. It was also important to our client that they be able to maintain strategic oversight of BioPoint Quality consultants, while delegating tactical tasks to the team.