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pankaj_gupta79

Pankaj Gupta

@pankaj_gupta79

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

India
English, Hindi
About me
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) ✔ Hands-on experience with USFDA, EU (CEP), and international regulatory requirements ✔ Expertise in CTD/eCTD dossier preparation (Module 2 & 3) I specialize in: DMF Open Part & Closed Part preparation CTD Module 3 (Quality) documentation Gap analysis and audit readiness I focus on delivering audit-ready, compliant, and submission-ready documentation with complete confidentiality.... Read more

Skills

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pankaj_gupta79
Pankaj Gupta
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See my services

Technical Writing
I will prepare complete dmf dossier open and closed part for usfda eu cep
From$200 / projectMore details
Technical Writing
I will prepare audit ready dmf open and closed parts for regulatory submission
From$150 / projectMore details

Portfolio

Work experience

Head RA/QA

Chereso Lifesciences • Full-time

Mar 2021 - Present • 5 yrs 2 mos

Handling Site QA and RA activities in Herbal and Neutraceutical plant. Got CEP grant for Colchicine, Thiocolchicine. DMF's filed for ROW market.

Asst. Manager RA

Parabolic Drugs Limited • Full-time

May 2013 - Feb 2021 • 7 yrs 9 mos

Got complete regulatory exposure. Successfully faced USFDA, PMDA, EUGMP, KFDA, Cofepris. Filed 42 regulatory DMF's. 21 in US, 1 PMDA, got 8 CEP's granted. Handled EDQM and USFDA queries and got EIR for the site.

Quality Control Reviewer

Torrent Pharma • Full-time

May 2010 - Apr 2013 • 2 yrs 11 mos

Review and release of Finished Goods QC data.