Eviva Pharma provide CMC regulatory affairs support.
Our experience is mainly for applications with a high Chemistry and Manufacturing Controls (CMC) content such as new chemical entities for Investigational Medicinal Products Dossiers (IMPDs) and Investigational New Drugs (INDs) as well as later stage including predominantly generic and OTC Marketing Authorisation Applications (MAAs).
Eviva offer consultancy service in:
- CMC regulatory affairs
- CMC consulting services
- CMC due diligence
- CMC Gap Analysis on IMPD (CTX) /NDA/MAA
- IND submissions
- Expert Reports or Quality Overall Summaries – Module 2.3 (Author of over 80)
- CMC Regulatory Strategy
- Module 3 preparation and review
Please contact us to see if we can help with the Regulatory support of your product.