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I will be your consultant for dmf compilation and ectd submission
PhD Chemist and Regulatory Specialist: Pharma, Cosmetic, Dietary Supp
With a Ph.D. in chemistry and 9+ years in regulatory affairs, I specialize in pharmaceutical and cosmetic compliance. Expertise includes:
• Pharma Regulation: Submitting marketing authorization applic...
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
Expert DMF & eCTD Consultant | Ensure Flawless FDA Submission & Avoid Costly Rejection
Launching a drug product is complex. A deficient Drug Master File (DMF) or non-compliant eCTD submission can lead to FDA deficiency letters, causing delays, high costs, and jeopardizing your launch. You need a strategic partner who understands FDA requirements, not just a writer.
As a Regulatory Affairs consultant specializing in DMF compilation and eCTD submission for USFDA, EMA, and MHRA, I transform complex CMC data into compliant, compelling dossiers for smooth regulatory reviews.
️WHY HIRE ME FOR YOUR DMF/eCTD NEEDS?
Reduce Risk of FDA Rejection: Meticulous approach avoids common pitfalls.
Deep Regulatory Expertise: 8+ years navigating 21 CFR, ICH guidelines, and CTD requirements.
End-to-End Support: From raw data to accepted submission.
WHAT MY SERVICE INCLUDES:
Comprehensive DMF Authoring: Modules 1, 2, and 3.
Strict CTD Formatting: ICH eCTD standards with hyperlinking.
Claim & Data Verification: Ensures accuracy of CMC data.
eCTD Readiness: Organized folder structure and PDFs.
Strategic Guidance: Expert regulatory advice.
Message me to discuss your DMF need and timeline.
Document type:
Technical Specifications
•
Regulatory Documents
Industry:
Medical & biotech
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
My Portfolio
FAQ
What information do you need from me to start the DMF compilation?
To provide an accurate quote and begin work, I typically need your CMC data. This includes the API synthesis report, quality specifications & (COA), analytical procedure and validation, stability data, packaging information, and any existing drafts or previous regulatory correspondence.
How do you ensure the confidentiality of my proprietary data?
Confidentiality is my utmost priority. I am willing to sign a comprehensive Non-Disclosure Agreement (NDA) before any information exchange. All data is stored on secure, encrypted systems and is never shared with any third party.
What is your experience with USFDA submissions, and can you share examples?
I have over +8 years of experience in regulatory affairs, with a proven track record of successful DMF submissions and ANDA/NDA submissions. While I cannot share specific client documents due to confidentiality, I can discuss general case studies and my approach to common challenges during our call.
What is the typical turnaround time for the Complete DMF Compilation package?
The timeline depends on the complexity of the product and the volume of data. Typically, a complete Type II DMF compilation takes between 2-8 weeks from receiving all necessary materials. Rush services may be available for an additional fee.
Do you handle the actual eCTD submission via the FDA ESG portal?
Yes, that is included in the Premium Package. For the Standard Package, I provide you with the fully validated, eCTD-ready folder. You can then submit it yourself, or I can guide you through the process.
