Equipping Tomorrow’s Leaders: DPSRU’s Practical Workshop on Dossier Filing and Regulatory Strategy

Bureau Chief Vijay Gaur - New Delhi

The Department of Industrial Pharmacy & Drug Regulatory Affairs, School of Pharmaceutical Sciences, Delhi 

Pharmaceutical Sciences and Research University (DPSRU) successfully conducted a two-day workshop-cum-hands-on training on “Dossier Preparation and Filing” on 21st and 22nd July, 2025 in collaboration with DIIF. The event was conducted with the aim to bridge the gap between academic learning and regulatory practice by offering students deep insights into the global regulatory landscape and the practicalities of dossier compilation & submission, as per the vision of Prof. Ravichandiran V, Hon’ble Vice Chancellor, DPSRU.
The first day of the workshop started with an inaugural ceremony including a warm reception of the guests, a formal welcome address, Saraswati Vandana, lamp lighting ceremony, and the singing of the DPSRU Kulgeet, all of which set a respectful and enthusiastic tone for the day. The coordinator for the workshop, Prof. Geeta Aggarwal, provided an overview of the workshop’s purpose and its relevance to the pharmaceutical industry. Prof. Harvinder Popli introduced regulatory affairs and the industry scenario, highlighting the importance of early understanding of global frameworks and illustrating their impact on product approvals with real-world examples. Dr. Mukesh Nandave, Incharge, SPS, DPSRU, discussed the importance of clinical trials in dossier preparation and emphasized the need for collaboration and skill development. The coordinators of this workshop Dr. Minakshi Garg, and Dr. Amanpreet Kaur, and Co-coordinators, Dr. Sushma Talegaonkar, Dr. Madhu Gupta, Dr. Sumit Sharma were also present.
The technical sessions for the day began with a highly informative session by Ms. Renu Gupta, Director – Commercial QA & Regulatory Affairs, JAPAC at Beckman Coulter, accompanied by her team. With over 18 years of experience in the healthcare and medical devices industry, Ms. Gupta provided a comprehensive overview of global medical device regulations, covering critical aspects of regulatory pathways in the USA, EU, Australia, and India. Her session included the definition and classification of medical devices, the regulatory approval processes, and specific requirements for each region. She also emphasized the need for risk-based classification, conformity assessments, and key documentation necessary for regulatory compliance followed by case studies.
Ms. Gupta and her team explained the step-by-step procedure for medical device registration, including how to navigate frameworks like the USFDA’s 510(k) and PMA routes, the European MDR 2017/745, and Australia’s TGA pathways. Her presentation also touched upon India's regulatory structure under CDSCO, highlighting the current classification system and dossier components in alignment with Indian guidelines.The next session was delivered by Mr. Manish Ragtah, Regulatory Affairs Manager at Beckman Coulter. Drawing from over 12 years of industry experience—including roles at Roche Diagnostics, Siemens Healthineers, Bard, and CDSCO—Mr. Ragtah offered a hands-on demonstration of the CDSCO’s SUGAM portal. Participants were guided through the real-time online process of submitting applications for the registration, renewal, and approval of medical devices and in-vitro diagnostic products in India.
 
 
His session included a walkthrough of the application modules, dossier checklists, and document uploading process, including the use of forms like MD-14 for import licenses and the importance of certifications such as ISO 13485, Free Sale Certificates, and Audit Reports. The session provided practical clarity on how dossiers are compiled and electronically submitted via India’s regulatory system, making the learning experience tangible and industry-relevant.
Adding to the engaging learning environment, a quiz round was conducted, which proved to be a fun, interactive, and intellectually stimulating activity. Participants enthusiastically took part, demonstrating their attentiveness and eagerness to apply the knowledge gained throughout the day. The quiz covered a range of critical regulatory concepts, including the classification of medical devices under USFDA, EU MDR, and CDSCO guidelines, essential documentation for dossier preparation such as ISO 13485 certificates, Free Sale Certificates, and Audit Reports, as well as regulatory approval pathways like 510(k), PMA, CE marking, and the CDSCO’s SUGAM portal. It also tested understanding of application forms such as MD-14 and MD-15. This session not only reinforced key learning outcomes but also encouraged active recall, teamwork, and a deeper understanding of the dossier compilation and submission process in a dynamic and enjoyable format.  
The first day concluded with enthusiastic interaction and questions from participants, reflecting their engagement and curiosity. Overall, the sessions provided a robust foundation in both theoretical and applied aspects of dossier preparation and filing, specifically within the context of global medical device regulations.
The second day of the workshop-cum-hands-on training commenced with the arrival of the esteemed speakers including Mr. Kaushik Anand, Senior Manager, Regulatory Operations at Alcon Laboratories (India) Pvt. Ltd., his team and other industry experts.
Mr. Anand initiated the session with a foundational introduction to the concept of dossier preparation, elaborating on its critical role in ensuring regulatory compliance and enabling market access for medical devices. The presentation then covered global regulatory frameworks, focusing on IMDRF, EU MDR, USFDA, and CDSCO standards. He emphasized the importance of adhering to harmonized dossier submission structures to promote clarity, cost efficiency, and adaptive regulatory practices.
The session further explored key dossier formats, particularly the Common Technical Document (CTD) and Summary Technical Documentation (STeD), providing a comparative analysis of their structure, usage, and regional applicability. Attendees were introduced to the essential components of a regulatory dossier, including administrative details, non-clinical and clinical evidence, labeling requirements, and quality management systems.
Mr. Anand also guided the participants through the chapter-wise breakdown of dossier content, explaining the contextual significance of submission background, device classification, design history, risk assessment, and post-market surveillance. The use of real-world case studies added practical value by demonstrating successful dossier submissions, common challenges, and the strategic solutions adopted.
The session concluded with an insightful overview of best practices for dossier preparation and submission. This included the importance of documentation accuracy, the utility of regulatory checklists, formatting consistency, staying updated with regulatory changes, and adhering to structured review timelines.
Throughout the session, Mr. Anand actively engaged with the audience, taking up questions and addressing students' doubts with detailed and practical explanations, making the session highly interactive and insightful.
As a gesture of appreciation, a vote of thanks was delivered by Dr. Amanpreet Kaur, acknowledging the speaker's valuable contribution and the participants’ active involvement. The event came to a close with the National Anthem, marking the successful conclusion of the two-day workshop on a patriotic and uplifting note.
Dr. Madhu Gupta, Associate Professor and PRO at DPSRU, shared comprehensive insights to the Bureau chief Shri Vijay Gaur about this two-day workshop-cum-hands-on training successfully bridged theoretical knowledge with practical application, offering participants a comprehensive understanding of dossier preparation and submission processes. Emphasis on global regulatory expectations, documentation precision, and strategic submission planning has equipped attendees with essential competencies to navigate the evolving landscape of medical device regulations. The program not only enhanced technical proficiency but also fostered a regulatory mindset crucial for compliance and successful market access.

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