CDSCO Drug & Device Master files
Budget: ₹1,500 – ₹12,500 INR
I am preparing both a Drug Master File and a Device Master File for submission to the CDSCO (Indian FDA) and need an expert who has already taken similar dossiers from draft to approval. My immediate priority is compiling and refining every section the regulator scrutinises—especially Quality Control data, detailed Manufacturing Process descriptions, and all relevant Clinical Data.
If you have hands-on experience navigating the CDSCO guidelines, structuring documents in CTD/eCTD format, and responding to technical queries raised through the SUGAM portal, I would like to work with you. Please tell me about the master files you have prepared or defended in the past and highlight any successful Indian approvals.
Key deliverables
• Complete, submission-ready Drug Master File (pharma)
• Complete, submission-ready Device Master File (medical device)
• Integrated QC, manufacturing, and clinical sections that align with current CDSCO checklists
• Supporting appendices, certificates, and formatting compliant with Indian FDA expectations
I will be available to provide raw test reports, batch records, and study results; your role is to organise, gap-assess, and present them so they satisfy the regulator first time. Let me know your turnaround time and how you prefer to collaborate on document reviews and updates.
If you have hands-on experience navigating the CDSCO guidelines, structuring documents in CTD/eCTD format, and responding to technical queries raised through the SUGAM portal, I would like to work with you. Please tell me about the master files you have prepared or defended in the past and highlight any successful Indian approvals.
Key deliverables
• Complete, submission-ready Drug Master File (pharma)
• Complete, submission-ready Device Master File (medical device)
• Integrated QC, manufacturing, and clinical sections that align with current CDSCO checklists
• Supporting appendices, certificates, and formatting compliant with Indian FDA expectations
I will be available to provide raw test reports, batch records, and study results; your role is to organise, gap-assess, and present them so they satisfy the regulator first time. Let me know your turnaround time and how you prefer to collaborate on document reviews and updates.