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

1. Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (CoA) (Annexure-2)
3. 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