API files
DMF and CEP references, specifications, impurity profiles and manufacturer evidence.
Service / Regulatory
Documentation that keeps decisions moving.
Sky Pharma
The right document package for the product and authority.
We coordinate the technical and regulatory information attached to APIs, excipients and finished dosage forms, helping reduce avoidable gaps during qualification, registration and audit.
01DMF and CEP coordination
02CoA and technical-file review
03CTD/eCTD dossier support
Service scope
What this includes.
Batch documentation
Certificates of Analysis and supporting quality records linked to the supplied material.
Registration dossiers
CTD/eCTD preparation and coordination for finished dosage forms and market submissions.
Lifecycle support
Variations, renewals, authority questions and audit-document follow-up.
Quality & evidence
Typical technical-file contents.
- Certificate of Analysis
- Stability data and impurity profile
- Residual-solvent and ICH Q3D information
- TSE/BSE statements
- GMP and GDP certificates
Discuss your requirement.