A Dubai based innovative healthcare and consumer products company had concerns with submissions of eCTD dossiers to SFDA. The client consulted Freyr for the Gap Analysis, review of administrative documents, drafting of module-1 to 5 documents, publishing and validation of eCTD dossier, sharing the finalized dossier with client in CD’s for SFDA submission.
This case study covers the details of the project, how Freyr supported the client in compilation and filing of drug product application to SFDA. Read through.