Developing Standard Operating Procedures for Global Dossier Compilation

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A Renuka

MAHGU

Dhaid Gaon, Block Pokhra , Uttarakhand, India

raorenuka2@gmail.com

Abstract
Developing robust Standard Operating Procedures (SOPs) for global dossier compilation is a foundational element in ensuring both regulatory compliance and operational excellence within multinational pharmaceutical and biotechnology organizations. In the rapidly evolving landscape of global health product development, companies face a growing array of divergent requirements—from submission formats and content expectations to timelines and post-submission commitments—across major regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, China’s NMPA, and Brazil’s ANVISA. The absence of harmonized, detailed SOPs can result in inconsistent dossier structure, version control errors, redundant review cycles, and ultimately, delays in product approvals that carry significant financial and patient-health implications.

This study articulates a comprehensive, modular framework for SOP development, tailored specifically to the end-to-end dossier assembly process in a global context. Drawing upon an extensive document analysis of legacy SOPs from five multinational corporations, in-depth interviews with 15 regulatory experts collectively representing over 180 years of experience, and a three-month pilot implementation within a mid-sized pharmaceutical regulatory affairs team, we identify and validate five critical SOP modules: (1) dossier template standardization, (2) document lifecycle and version control, (3) cross-functional review workflows, (4) risk-based quality checkpoints, and (5) approval and archiving procedures.

Keywords

Global dossier compilation, Standard operating procedures, Regulatory submissions, Document management, Quality assurance

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