Standard Operating Procedure for Pre-Submission Meeting with Regulatory Authorities in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/020/2025
Supersedes	SOP/BA-BE/020/2022
Page No.	Page 1 of 12
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a structured procedure for initiating, planning, conducting, and documenting pre-submission meetings with regulatory authorities (e.g., CDSCO, USFDA, EMA) prior to submitting Bioavailability/Bioequivalence (BA/BE) study applications or dossiers.

2. Scope

This SOP applies to Regulatory Affairs, Clinical Development, and R&D personnel involved in interactions with regulatory agencies for scientific advice, clarification on study design, waiver strategy, and dossier expectations in BA/BE submissions.

3. Responsibilities

• Regulatory Affairs: Initiates the meeting request, coordinates preparation of briefing documents, and manages communication with regulatory bodies.
• Clinical & Bioanalytical Teams: Provide technical input and clarification on the proposed study design and methodology.
• Medical Affairs: Participates in the meeting and provides clinical rationale and justifications.
• Documentation Lead: Records minutes and circulates post-meeting action points.

4. Accountability

The Director – Regulatory Affairs is accountable for ensuring that pre-submission meetings are conducted with appropriate preparation, alignment, and documentation to support the BA/BE submission strategy.

5. Procedure

5.1 Meeting Request Initiation

1. Identify the need for a meeting based on:
   • Complex study design
   • Need for waivers
   • Ambiguities in product-specific guidance
   • Uncertainty in local regulatory requirements
2. Submit formal request per agency guidelines:
   • CDSCO: Submit request via SUGAM portal
   • USFDA: Use Type B meeting request format
   • EMA: Submit scientific advice request through IRIS portal
3. Log request in Annexure-1: Meeting Request Log.

5.2 Preparation of Briefing Package

1. Compile briefing package containing:
   • Study background and objective
   • Proposed study design and rationale
   • Questions for agency (categorized as clinical, analytical, regulatory)
   • Data to support the request
2. Submit briefing document at least 2–4 weeks prior to scheduled meeting date.
3. Maintain version-controlled copy in eTMF and Annexure-2: Briefing Document Tracker.

5.3 Internal Pre-Meeting Preparation

1. Schedule internal mock meeting with stakeholders.
2. Assign speaking roles and prepare backup responses to anticipated questions.
3. Share finalized presentation materials with participants in advance.

5.4 Conduct of Meeting

1. Attend the meeting as scheduled (physical/virtual).
2. Ensure that:
   • Designated spokesperson addresses questions
   • Discussion is focused and professional
   • All attendees sign attendance record (Annexure-3)

5.5 Post-Meeting Activities

1. Prepare draft meeting minutes within 3 business days.
2. Circulate for internal review and submit to agency for confirmation if required.
3. Log action items in Annexure-4: Regulatory Advice Action Tracker.
4. Update protocol and regulatory strategy as needed based on discussion outcomes.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CDSCO: Central Drugs Standard Control Organization
• EMA: European Medicines Agency
• eTMF: Electronic Trial Master File

7. Documents

1. Meeting Request Log – Annexure-1
2. Briefing Document Tracker – Annexure-2
3. Meeting Attendance Record – Annexure-3
4. Regulatory Advice Action Tracker – Annexure-4

8. References

• USFDA Guidance on Formal Meetings with Sponsors
• EMA Scientific Advice and Protocol Assistance Guidelines
• CDSCO Handbook for Applicants – SUGAM Portal

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Meeting Request Log

Date	Agency	Request Type	Status	Requested By
01/04/2025	CDSCO	Scientific Advice	Accepted	Rajesh Kumar

Annexure-2: Briefing Document Tracker

Version	Date	Prepared By	Reviewed By	Status
V1.0	03/04/2025	Sunita Reddy	QA	Submitted

Annexure-3: Meeting Attendance Record

Name	Designation	Department	Signature
Dr. Aarti Deshmukh	Regulatory Manager	Regulatory Affairs

Annexure-4: Regulatory Advice Action Tracker

Date	Advice Given	Follow-Up Action	Status
06/04/2025	Clarify PK sampling duration	Updated protocol V2.1	Completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Added Annexures and clarified IRIS/SUGAM submission flows	Regulatory Alignment	QA Head