I will prepare audit ready dmf open and closed parts for regulatory submission

India

I speak English, Hindi

Regulatory Affairs and QA Consultant, API, Pharma,DMF ,e CTD , Audit Readineness

Regulatory Affairs Consultant with 20+ years of experience supporting API/pharmaceutical and Herbal companies in global submissions. ✔ Successfully prepared and filed 40+ Drug Master Files (DMFs) ✔ H...

About this Gig

I am a Regulatory Affairs expert with 20 years of experience in QA, QC, and DMF preparation. I will prepare your DMF Open Part, Closed Part, or full DMF in CTD format with professional technical writing, formatting, and technical illustrations.

My services include process flow diagrams, tables, figures, gap analysis, and regulatory-compliant content to help you submit your DMF confidently.

Packages available for Basic (Open Part), Standard (Open Part Advanced), and Premium (Full DMF). All work includes proofreading, formatting, and revisions. Suitable for API manufacturers, pharmaceutical companies, and international regulatory submissions.