IJRMP – Vol.15- 2026
-
Implementation Challenges in eCTD Submissions Across Regulatory Regions
The electronic Common Technical Document (eCTD) has become the cornerstone of global regulatory submissions, offering a harmonized structure for dossier assembly, data integrity, and lifecycle management. Since its inception under ICH M4 in 2002, successive versions…
-
Tracking Metrics for Regulatory Submission Performance in Multinational Portfolios
Effective management of regulatory submission performance across multiple jurisdictions directly influences a company’s ability to bring life-saving therapies to patients in a timely manner. This expanded study analyzes key performance indicators—submission timelines, approval rates, and regulatory…
-
Vol. 15, Issue 3, March 2026
Sr. Title of Research Paper/Article Author e-Certificate Download Confirmation Letter 1 Tracking Metrics for Regulatory Submission Performance in Multinational Portfolios Dr Rambabu Kalathoti Download PDF 2 Implementation Challenges in eCTD Submissions Across Regulatory Regions Dr.…
-
Gap Assessment Frameworks for Post-Approval Regulatory Compliance
Post-approval regulatory compliance remains a cornerstone of pharmaceutical quality assurance, ensuring that products on the market continuously adhere to evolving safety, efficacy, and quality standards. Following initial market authorization, manufacturers face myriad challenges: real-world safety signal…
-
The Role of Regulatory Affairs in Lifecycle Management of Generic Drugs
The lifecycle management of generic drugs encompasses the continuum of activities from initial regulatory submission through post-marketing surveillance, product variation, and eventual discontinuation. Regulatory affairs (RA) professionals serve as strategic linchpins, interpreting evolving guidelines, coordinating cross-functional…
-
Cross-Functional Collaboration Models in Regulatory Project Execution
Cross-functional collaboration is an essential strategic approach employed by life sciences organizations to address the increasing complexity of regulatory requirements and compress ever-tightening submission timelines. While traditional siloed structures impede information flow and prolong decision cycles,…
-
Developing Standard Operating Procedures for Global Dossier Compilation
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…
-
Impact of Regulatory Delays on Product Launch Timelines: A Risk-Based Study
— Regulatory approval processes are critical checkpoints in the lifecycle of new products, yet delays in these processes can significantly impede time to market, impacting organizational competitiveness and revenue streams. This study adopts a risk-based perspective…
-
Vol. 15, Issue 2, February 2026
Sr. Title of Research Paper/Article Author e-Certificate Download Confirmation Letter 1 Impact of Regulatory Delays on Product Launch Timelines: A Risk-Based Study Prof. (Dr) Sangeet Vashishtha Download PDF 2 Developing Standard Operating Procedures for Global…
-
Automation in Regulatory Document Compilation for ANDA Submissions
— The submission of an Abbreviated New Drug Application (ANDA) to regulatory agencies such as the U.S. Food and Drug Administration (FDA) necessitates the assembly of extensive technical, scientific, and administrative documentation. Traditionally, this process has…