Preparing Regulatory Submissions in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for preparing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating timely approvals.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the preparation of regulatory submissions for new formulations, changes, or renewals.

3) Responsibilities

The responsibilities for this SOP include:
Regulatory Affairs: Leading and coordinating regulatory submission activities, ensuring submissions are complete and accurate.
Project Manager: Providing project-specific information and supporting regulatory affairs in preparing submissions.
Quality Assurance: Reviewing and approving submission documents to ensure compliance with regulatory standards.
Formulation Development Team: Providing technical data, reports, and other necessary information for submission.

4) Procedure

4.1 Regulatory Strategy Development

1. Develop a regulatory strategy based on project objectives, product characteristics, and regulatory requirements.
2. Identify regulatory pathways (e.g., new drug application, abbreviated new drug application) and submission requirements.
3. Obtain approval for the regulatory strategy from stakeholders and management.

4.2 Compilation of Submission Documents

1. Gather technical data, reports, and documentation required for the regulatory submission.
2. Prepare submission documents, including but not limited to:
   • Chemistry, Manufacturing, and Controls (CMC) section
   • Preclinical and clinical data summaries
   • Stability data and reports
   • Quality control and assurance documents
3. Ensure all documents are accurate, complete, and formatted according to regulatory guidelines.

4.3 Submission Preparation and Assembly

1. Organize and assemble submission documents according to the regulatory agency’s requirements (e.g., electronic format, specific sections).
2. Include necessary forms, declarations, and supporting documentation as required by regulatory authorities.
3. Verify completeness and accuracy of the submission package before submission.

4.4 Submission to Regulatory Authorities

1. Submit the compiled regulatory package to the appropriate regulatory authority within the specified timeline.
2. Track submission status and respond to requests for additional information or clarification promptly.
3. Collaborate with regulatory agencies during the review process and provide additional data or clarifications as needed.

4.5 Archiving and Record Keeping

1. Archive a copy of the final submission package and related correspondence for future reference and regulatory inspections.
2. Maintain records of all regulatory submissions, approvals, and amendments in accordance with company policies and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CMC: Chemistry, Manufacturing, and Controls

6) Documents, if any

Regulatory Strategy Document
Submission Documents
Correspondence with Regulatory Agencies
Archived Submission Package

7) Reference, if any

– ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
– FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format

8) SOP Version

Version 1.0