REGULATORY AFFAIRS

Cuphea manages end to end to services and solutions falling under the umbrella of regulatory affairs

Regulatory intelligence for new markets

Dossier writing and compilation

Gap analysis and Remediation of documents

CMC writing and review

Medical writing and review

Safety and PV studies

Review of Technical files

Publishing and Submissions

Health Authority correspondences

New Product Authorizations – API and Finished

Market Authorization Applications

DMF/ASMF/CTD/ACTD/Emerging markets dossiers

Product Lifecycle management