Devki Patel Email & Phone Number

Ahmedabad, Gujarat, India

I am happy share that I have joined Corona Remedies Private Limited as an Assistant Manager in Regulatory Department and eager to learn, grow and contribute to my new role.

Gandhinagar, Gujarat, India

+ Currently working in a deficiency team to evaluate, draft, compilation of query response within the stipulated timeline for different countries.+ Having exposure of handling queries of different region like Australia, APAC region (Taiwan, Thailand, Malaysia, Singapore, Philippines, Indonesia, Hong- Kong, Vietnam, Myanmar) AFME region (Tanzania, Uganda, Ethiopia, Kenya, Rwanda & FWA), MENA region (Saudi Arabia and Jordan) and LATAM region (Bolivia, Chile, Colombia, Costa-rica, Panama and… Show more + Currently working in a deficiency team to evaluate, draft, compilation of query response within the stipulated timeline for different countries.+ Having exposure of handling queries of different region like Australia, APAC region (Taiwan, Thailand, Malaysia, Singapore, Philippines, Indonesia, Hong- Kong, Vietnam, Myanmar) AFME region (Tanzania, Uganda, Ethiopia, Kenya, Rwanda & FWA), MENA region (Saudi Arabia and Jordan) and LATAM region (Bolivia, Chile, Colombia, Costa-rica, Panama and Uruguay)+ Entry in DRMS (deficiency response management system) portal to get the query trend for different markets and updation of market-specific dossier checklist to reduce the queries and improve overall quality of the dossiers.+ To coordinate and discuss with cross-functional team and technical departments at plant level in order to submit the query response within stipulated timeline.+ Submission of pharmacopoeial updation variation for finished product, API and excipients.+ Also having experience of writing, reviewing and submitting ACTD and CTD dossiers as as per the country specific regulations, variation filing, site registration and Life Cycle Management of finished product. +Responsible for handling the labeling requirement, for licensing activities i.e. Certificate of Pharmaceutical Product (COPP), Product Permission (PP), Free sale Certificate (FSC) etc. Review of commercial and supporting document such as Master Formula Records, Pharmaceutical Development Record, Finished product Specification & Method of Analysis, Stability data, Process Validation, Analytical Method Validation, CDP etc.Markets: Australia, APAC, AFME, LATAM and MENA Show less

Gandhinagar, Gujarat, India

Working in semi regulatory markers.

Domain: Dossier Preparation (Injectable), COPP Application, Artwork preparation, Samples dispatch.Markets: APAC and AFME