In the pharmaceutical industry, expanding beyond core markets requires meticulous planning and rigorous documentation. For manufacturers targeting the Rest of the World (ROW) markets, the preparation of a complete and compliant regulatory dossier is the gateway to product registration and sales.
This process is highly structured and governed by internal procedures to ensure that every submission meets the unique, often demanding, requirements of the target country's regulatory body.
The Regulatory Affairs SOP: Dossier Preparation Procedure
A robust Standard Operating Procedure (SOP) guides the entire dossier compilation process, clearly defining roles, responsibilities, and the sequence of documentation management.
1. Initiation and Scope (The Request)
The dossier preparation activity officially begins with the receipt of the Dossier Request Form (DRF) from the Marketing department. This request formalizes the need to register a product in a new region. The scope of the procedure covers the preparation and compilation of the full regulatory dossier for any target ROW market.
2. Defining Roles and Responsibilities
Success hinges on clear accountability across departments:
| Role | Responsibility |
| Officer/Executive – Regulatory Affairs (RA) | Reviews documents for adequacy, coordinates collection, and prepares the final submission dossier. |
| Asst. Manager/Manager – RA | Responsible for the final review of the compiled dossier before submission to ensure completeness. |
| Head of Regulatory Affairs | Holds ultimate accountability for the approval of the SOP and the overall submission strategy. |
3. Gathering Country-Specific Regulatory Guidelines
Regulatory guidelines vary drastically between countries. Relying on outdated or generic checklists is a critical risk.
- Action: The RA team must coordinate with the Marketing department and/or directly access the official website of the target country's regulatory authority to obtain the latest, definitive guidelines.
- Team Assignment: A specific individual or team is assigned to manage the project, ensuring focus and accountability.
4. The Dossier Checklist and Document Status
Based on the official country guidelines, a detailed dossier checklist is created.
- Internal Confirmation: RA must first confirm the formulation, specifications, process, and method of analysis with R&D, Quality Assurance (QA), and Production.
- Gap Analysis: A status is drawn for all required documents against the checklist. Only documents not currently available within the RA department are requested from other functional areas.
5. Document Collection and Coordination
Regulatory Affairs acts as the central hub, coordinating and collecting different categories of documents:
| Document Category | Source Department |
| Quality Documents (Specifications, Test Methods, Stability Data) | R&D, Corporate QA (CQA), Quality Control (QC), and Site QA |
| Clinical and Non-clinical Documents (Study Reports) | R&D |
| Administrative Documents (GMP Certificate, Manufacturing License) | Liaisoning Department |
| Product Artworks (Labels, Inserts) | Packaging Development Department |
| Literature References | Internet/Library Services |
| Drug Master File (DMF) (Open Part) | Purchasing Department (if applicable) |
6. Validation, Compilation, and Final Checks
Before assembly, every document is rigorously checked against the country’s regulatory requirements:
- Adequacy Check: Documents are checked for completeness, compliance, and format. If corrections are needed, they are returned to the concerned department immediately for revision.
- Compilation: The dossier is compiled according to the checklist, ensuring proper order, numbering, and referencing.
- Final Verification: The completed dossier is subjected to a final check for correctness and completeness by the Regulatory Manager before being released.
7. Submission and Post-Submission
The compiled and approved dossier is then released.
- Delivery: Upon final confirmation from the Marketing team, the documents are securely sent to the concerned agent and/or client in the ROW country for official registration submission.
- Follow-Up: The RA team remains responsible for authoring any subsequent correspondence required by the regulatory agency during the review process.
Abbreviations Used
| Abbreviation | Full Form |
| SOP | Standard Operating Procedure |
| COPP | Certificate of Pharmaceutical Product |
| DRF | Dossier Request Form |
| DMF | Drug Master File |
| GMP | Good Manufacturing Practice |
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