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 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.
- Perform trial GMP compliance audits of the contract manufacturing facilities to verify their readiness for the HA audit
- Complete gap analysis of the facilities, problems and suggesting possible remedies
- Regulatory submissions for site transfers and addition of new manufacturing sites
- The services offered by Freyr include but are not limited to:
- End-to end support during product development, along with strategic Regulatory inputs
- Designation of drug substances, starting materials, excipients, packaging materials and drug products
- Designation of process validation protocol, stability protocol, hold time study protocol, etc.
- Technical review of all manufacturing documents and submission documents
- Support for designing the protocols for the manufacturing of pilot batches, exhibit batches and commercial batches
- Support in selecting parameters/multimedia/for performing Dissolution for Test product and Reference Listed Drug (RLD)
- Compilation, review and submission of dossiers for drug substances and drug products to HAs across the globe
- Strategic support in the evaluation of post approval changes and providing the variation submission strategy
- Compilation, review and submission of post approval submissions and life cycle management activities