Compilation, review, dossiers submission, GMP compliance, CMO

Nowadays, most pharmaceutical companies, research institutes and life-science suppliers rely on contract manufacturers to meet their product development and manufacturing needs. To maintain the high-quality product standard, the contractor’s facility should be Good Manufacturing Practice (GMP) certified (PICs approval, Local GMP, etc.). Contract manufacturers register their products across the globe depending upon their client’s requirements. As such, contract manufacturers should be aware of global requirements, should strictly follow manufacturing guidelines and should ensure that the facility is audit-ready for the health authorities (HAs) they’re dealing with.

In such scenarios, Regulatory Affairs team play a key role in decoding the current GMP requirements. Freyr, a global Regulatory service provider, has a very strong Regulatory team to support contract manufacturing organizations pharmaceutical with extensive experience in different regions across the world. Currently, Freyr deals with various projects like initial submissions, post approval activities, life cycle management, and so on.