Standard Operating Procedure for Regulatory Submission Planning and Tracking
| Department | Regulatory Affairs |
| SOP No. | RA/2026/201 |
| Supersedes | NA |
| Page No. | 1 of 1 |
| Issue Date | 07/04/2026 |
| Effective Date | 07/04/2026 |
| Review Date | 07/04/2028 |
Purpose
This Standard Operating Procedure (SOP) provides a systematic framework for the planning, preparation, submission, and tracking of regulatory submissions to health authorities. It is essential to ensure compliance with applicable regulatory requirements, maintain transparency, and streamline communication during the regulatory submission process. The objective is to facilitate timely submissions, reduce errors, and enhance tracking efficiency to support product approvals and lifecycle management.
Scope
This SOP applies to all Regulatory Affairs personnel involved in the planning, preparation, compilation, submission, and tracking of regulatory dossiers for pharmaceutical products to global and national regulatory agencies. It covers submission types including new drug applications, variations, renewals, amendments, and safety reports. This SOP encompasses internal coordination, document management, timeline tracking, and communication with external agencies, excluding manufacturing and post-marketing surveillance activities.
Responsibilities
- Regulatory Affairs Manager: Oversees regulatory submission planning, ensures compliance, reviews submissions, and liaises with health authorities.
- Regulatory Affairs Executive: Prepares submission documents, coordinates data collection, and maintains submission timelines.
- Quality Assurance: Reviews documentation for compliance with quality standards and good documentation practices.
- Document Control Team: Manages version control and secure storage of submission-related documents.
- Project Coordinator: Tracks submission progress, schedules meetings, and updates stakeholders on regulatory status.
Accountability
The Regulatory Affairs Head is accountable for ensuring adherence to this SOP, maintaining submission accuracy, compliance with regulatory timelines, and resolving deviations related to submission planning and tracking.
Procedure
1. Submission Planning and Initiation:
Upon identification of a regulatory submission requirement, the Regulatory Affairs Manager initiates the submission plan. The Manager defines submission type, regulatory requirements, and target submission date. Key milestones and resource allocation are documented in the submission tracking tool.
2. Document Collection and Compilation:
Regulatory Affairs Executives coordinate with cross-functional teams including Clinical, Quality, and Manufacturing to collect necessary documents and data. Each submission dossier is compiled following format guidelines, ensuring that all modules meet regulatory expectations.
3. Preliminary Review and Quality Check:
Completed dossiers undergo a preliminary review by the Regulatory Affairs Manager and Quality Assurance to verify completeness, adherence to guidelines, and internal quality standards. Any discrepancies or missing data are addressed promptly.
4. Submission and Confirmation:
The finalized dossier is submitted to the relevant authority through the designated electronic or physical channels. Receipt confirmation and acknowledgment are documented in the tracking system.
5. Tracking and Follow-up:
The Project Coordinator monitors submission status using the tracking tool, logs communications from the authority, and alerts team members of required actions or queries. Regular status updates are communicated to senior management.
6. Documentation and Record-Keeping:
All submission-related documents, correspondence, and reports are archived securely in line with company and regulatory record retention policies. Version control is maintained to ensure retrieval of accurate submission histories.
7. Training and Continuous Improvement:
Personnel involved in submissions attend periodic training to remain updated on regulatory changes and SOP adherence. Feedback from submission cycles is reviewed to refine procedures and improve efficiency.
Abbreviations
- RA: Regulatory Affairs
- SOP: Standard Operating Procedure
- CoA: Certificate of Analysis
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
- CTD: Common Technical Document
Documents
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (CoA) (Annexure-2)
- Approval and Release Form (Annexure-3)
References
International Council for Harmonisation (ICH) Guidelines, FDA Regulatory Submission Guidance, EMA Submission Requirements, WHO Technical Reports, and Company Quality Management System Documentation.
Version: 1.0
Approval
| Prepared By | Rajesh Kumar |
| Checked By | Sunita Reddy |
| Approved By | Jayprakash Khanduri |
Annexures
Annexure-1: Material Dispensing Log
| Date | Material Name | Batch Number | Quantity Dispensed | Dispensed By | Checked By |
|---|---|---|---|---|---|
| 01/04/2026 | Active Pharmaceutical Ingredient | B12345 | 500 kg | Suresh Nair | Priya Menon |
| 02/04/2026 | Excipients Blend | EX67890 | 1000 kg | Anita Sharma | Rajesh Kumar |
| 03/04/2026 | Packaging Material | PK11223 | 10,000 units | Mahesh Iyer | Sunita Reddy |
Annexure-2: Certificate of Analysis (CoA)
| Product Name | Batch Number | Test Parameter | Specification | Result | Tested By | Date |
|---|---|---|---|---|---|---|
| Paracetamol Tablets | PA2026-456 | Assay | 95-105% | 99.2% | Dr. Meera Gupta | 05/04/2026 |
| Paracetamol Tablets | PA2026-456 | Dissolution | Not less than 80% in 30 min | 85% | Dr. Meera Gupta | 05/04/2026 |
| Paracetamol Tablets | PA2026-456 | Microbial Limits | Conforms | Conforms | Dr. Sunil Rao | 05/04/2026 |
Annexure-3: Approval and Release Form
| Document Name | Version | Approved By | Approval Date | Remarks |
|---|---|---|---|---|
| Regulatory Submission Dossier | 1.0 | Jayprakash Khanduri | 07/04/2026 | Approved for submission |
| Submission Tracking Log | 1.0 | Rajesh Kumar | 06/04/2026 | Reviewed and cleared |
| Regulatory Communication Log | 1.0 | Sunita Reddy | 07/04/2026 | Approved for filing |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 07/04/2026 | 1.0 | Initial issue | New SOP creation | Amit Sharma |