Pimchanok Parpakittikun Email & Phone Number

Thailand

-Submitted the eCTD new drug application (NDA) classify under new chemical entity (NCE) for rare disease in Thailand. And pass the prescreening step without issue. Get approved 1 product license.-Expanded the territory market to Vietnam for 3 biological products registrations-To be the GMP clearance center of excellence which gets approval more than 40 applications. And attended in PReMA GMP clearance working group.-Organized and managed the eCTD baseline submission project.-To be point of contact for clinical trial application (CTA) and collaborated with clinical research organization (CRO) to implement the CTA in Thailand which get approval the import permit license for clinical trial.-Get approved more than 20 applications for the import permit license for donating drug to hospitals.-Submitted the variation for chemical drugs and biological products such as major variation which get approval without supply impact.-Organized the products transfer and divesture product project.-Maintained company licenses including GPP inspection and FDA report.-Quality Assurance(QA) supported: to be QA backup for batch released and any complaints, and attended to investigation the product deviation meeting.-Pharmacovigilance (PV) supported : reviewed the notification of safety information letter and the HPVC report. And submitted the 4-monthly ADR report and the summary of reminders and facilitation of ADR reporting form at 8 months to the Thai FDA.-Collaborated with the cross functional team such as commercial team for reviewed and submitted the promotional materials, and to be the oncology and hematology portfolios point of contact for product listing to hospital. Translated the COAs and provided the documents related regulatory for custom clearance to supply team.

-Submitted the bioequivalence report, dose proportional report and ACTD dossier including variations for new generic drug application along with responded the comments from Thai FDA.-Responded comments from Thai FDA for eCTD dossier of new generic drug submission.-Submitted and get approved the GMP clearance applications almost by PICs classification.-Get approved for the investigation import permit license and collaborated with CRO to monitor the bioequivalence studies at sits-Provided documents to support sales and marketing teams.-Coordinated with overseas partners to import and register product.-Participated in Good Distribute Practice (GDP) meeting by Thai FDA.

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พระประแดง, สมุทรปราการ, ประเทศไทย

พระประแดง, สมุทรปราการ, ประเทศไทย

กรุงเทพมหานคร, กรุงเทพมหานคร, ประเทศไทย