Regulatory Documentation & Dossier Preparation

Service Capabilities

Proper documentation is mandatory for securing regulatory approvals, product permissions, and maintaining GMP compliance. We support organizations in creating robust technical files.

Scope of Documentation Support

• Regulatory Dossiers: Preparation of dossiers for domestic State FDA and national DCGI approvals as well as international submissions.
• FDA / DCGI Coordination: Complete documentation preparation, online portal submissions, and query response coordination.
• Core GMP Documents: Site Master File (SMF), Quality Manual, Validation Master Plan (VMP), User Requirement Specifications (URS), DQ, IQ, OQ, PQ, PVP/PVR, and SOP drafting.
• Artwork & Labeling: Artwork development, designing, proofreading, and regulatory compliance review for secondary packaging.