Protocol for Compiling Regulatory Submissions for BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the preparation, compilation, and submission of regulatory documents for Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the regulatory submission process, including Regulatory Affairs Specialists, Study Coordinators, Data Managers, and Principal Investigators.

Responsibilities

• The Regulatory Affairs Specialist is responsible for coordinating the preparation and submission of regulatory documents, ensuring compliance with regulatory requirements and timelines.
• The Study Coordinator is responsible for providing study data, documentation, and study reports required for regulatory submissions.
• The Data Manager is responsible for preparing study datasets, data summaries, and statistical analyses for inclusion in regulatory submissions.
• The Principal Investigator is responsible for reviewing and approving regulatory documents, ensuring accuracy, completeness, and compliance with study protocols.

Procedure

1. Identify the regulatory requirements and submission deadlines for the specific jurisdiction(s) where the study will be conducted or where regulatory approval is sought.
2. Compile all required regulatory documents, including study protocols, investigator brochures, informed consent forms, case report forms (CRFs), and study reports.
3. Prepare a comprehensive regulatory submission package, including a cover letter, completed application forms, and supporting documentation required by regulatory authorities.
4. Review and verify the accuracy and completeness of all regulatory documents, ensuring consistency with study protocols, regulatory guidelines, and sponsor requirements.
5. Obtain approval from the Principal Investigator and other relevant stakeholders before finalizing the regulatory submission package.
6. Submit the regulatory package to the appropriate regulatory authorities, ensuring that all required forms are completed, signed, and submitted according to specified timelines and procedures.
7. Maintain records of all regulatory submissions, including submission dates, tracking numbers, correspondence, and regulatory approvals, in accordance with regulatory requirements.
8. Monitor regulatory submissions for any requests for additional information or clarification from regulatory authorities and provide timely responses as required.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRF – Case Report Form

Documents

• Regulatory Submission Package
• Regulatory Application Forms
• Correspondence Log
• Approval Forms

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for preparing regulatory submissions in clinical research.

SOP Version

Version 1.0