Standard Operating Procedure for Regulatory Operations Support to New Product Launches

Department	Regulatory Affairs
SOP No.	RA/2026/616
Supersedes	NA
Page No.	1 of X
Issue Date	08/04/2026
Effective Date	08/04/2026
Review Date	08/04/2028

Purpose

This Standard Operating Procedure (SOP) defines the systematic approach and control measures for providing comprehensive regulatory operations support during new product launches. It ensures compliance with applicable regulatory requirements, facilitates timely submission and approval processes, and supports cross-functional coordination to achieve successful market introduction of new pharmaceutical products in alignment with corporate quality and compliance objectives.

Scope

This SOP applies to all regulatory affairs personnel and associated functional areas involved in regulatory operations support related to new product launches. It covers the preparation, review, submission, tracking, and archiving of regulatory documentation and correspondences for new chemical entities, generic drugs, biologics, and dosage forms. This scope includes coordination with manufacturing, quality assurance, quality control, clinical, and supply chain departments. Activities outside the regulatory submission and operations support, such as clinical trial conduct or post-market surveillance, are excluded.

Responsibilities

• Regulatory Affairs Specialists – execute regulatory operations tasks, prepare and submit documentation, and maintain regulatory communication logs.
• Regulatory Affairs Supervisors – review and authorize regulatory submissions, ensure adherence to timelines, and supervise compliance with global regulations.
• Quality Assurance – support and verify regulatory documentation and compliance with GMP requirements.
• Cross-Functional Team Leads – provide inputs and ensure readiness of product dossiers and supporting data.
• Document Control – manage controlled distribution and archiving of regulatory documents related to the product launch.

Accountability

The Head of Regulatory Affairs is accountable for the implementation, compliance, periodic review, escalation of any deviations, and overall effectiveness of this SOP to ensure regulatory operations support aligns with internal policies and external regulatory expectations during new product launches.

Procedure

The procedure for providing regulatory operations support to new product launches is outlined below:

1. Preparation and Planning
Regulatory Affairs shall coordinate with project management and cross-functional teams immediately upon new product development initiation. This includes identifying applicable regulatory requirements, timelines, and documentation needed for submission. A regulatory strategy and submission calendar detailing milestones and responsible parties must be established and periodically updated.

2. Documentation Management
Prepare regulatory dossiers, including but not limited to Module 1 administrative information, technical sections, certificates of analysis, manufacturing details, labeling, and packaging information. Ensure all documents are created in compliance with current regulatory guidelines and internal standards, undergo necessary reviews, and are approved prior to submission.

3. Quality and Compliance Checks
Verify all documents and data for GMP compliance, completeness, and accuracy. Perform risk assessments to identify potential compliance gaps or regulatory concerns. Conduct internal audits or quality checks as necessary.

4. Submission and Interaction with Regulatory Authorities
Submit dossiers to regulatory authorities as per the agreed timelines and guidelines. Manage submission acknowledgments, queries, amendments, and communications efficiently, logging all interactions and responses in the regulatory tracking system. Escalate critical issues to management promptly.

5. In-Process Monitoring and Control
Track submission status and review progress regularly. Coordinate with regulatory bodies and internal departments to provide supplemental information or data in response to queries. Maintain communication transparency among all stakeholders.

6. Documentation and Record Retention
Ensure that all submission documents, correspondence, reports, and approvals are archived in designated controlled repositories according to company document control policies and regulatory requirements. Maintain records that allow complete traceability and audit readiness.

7. Deviations and CAPA Handling
Investigate any deviations from planned regulatory operations activities. Implement corrective and preventive actions (CAPA) in consultation with Quality Assurance and ensure documentation and reporting of such events.

8. Training and Awareness
Support appropriate training to involved personnel on regulatory requirements, submission procedures, and SOP updates relevant to new product launches.

9. Review and Continuous Improvement
Conduct periodic reviews of this SOP and regulatory operation outcomes related to new launches to identify improvement opportunities and incorporate changes according to evolving regulations or internal process enhancements.

Abbreviations

• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practice
• SOP: Standard Operating Procedure
• RA: Regulatory Affairs
• QA: Quality Assurance
• QC: Quality Control

Documents

Below are the documents specifically required for regulatory operations support during new product launches:

1. Regulatory Submission Checklist (Annexure-1)
2. Regulatory Query Response Log (Annexure-2)
3. Submission Tracking Report (Annexure-3)

References

• ICH Q10 Pharmaceutical Quality System
• FDA 21 CFR Part 314 – Applications for FDA Approval to Market a New Drug
• EMA Guidelines on the Preparation of Dossiers for Marketing Authorization
• Company Quality Management System Documentation
• GMP Regulations and Guidance Documents

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Regulatory Submission Checklist

Purpose: To ensure all required documents and data are prepared, reviewed, and completed before regulatory submission during new product launches.

Item	Description	Status (Yes/No)	Comments
1	Complete administrative information	Yes	All forms signed and dated
2	Module 2 summary documents	Yes	Cross-checked with technical teams
3	Module 3 quality documentation	Yes	Validated batch data included
4	Certificates of Analysis	Yes	Signed by QC head
5	Labeling and packaging artwork	Yes	Approved by QA
6	Regulatory authority forms	Yes	Completed and reviewed
7	Regulatory strategy documentation	Yes	Aligned with global requirements

Annexure-2: Regulatory Query Response Log

Purpose: To document all queries received from regulatory authorities and responses provided during the regulatory approval process of a new product launch.

Query No.	Date Received	Query Details	Date Responded	Response Summary	Status
Q001	15/02/2026	Clarification on stability data protocol	20/02/2026	Submitted detailed study report	Closed
Q002	01/03/2026	Additional information on manufacturing site	05/03/2026	Provided facility certification	Closed
Q003	18/03/2026	Request for updated batch analyses	23/03/2026	Submitted latest batch reports	Closed

Annexure-3: Submission Tracking Report

Purpose: To monitor and track the status of all regulatory submissions related to a new product launch.

Submission ID	Submission Date	Regulatory Authority	Submission Type	Status	Next Action Due	Comments
SUB12345	10/02/2026	FDA	New Drug Application	Under Review	20/04/2026	Waiting for formal acknowledgement
SUB12346	12/02/2026	EMA	Marketing Authorization	Accepted	Pending Queries	Initial assessment completed
SUB12347	15/02/2026	PMDA	Shonin Application	In Progress	30/04/2026	Coordination for query response ongoing

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
08/04/2026	1.0	Initial issue	New SOP creation