Arvind Suthar Email & Phone Number

• To prepare and dispatch dossier as per country registration guideline (CTD, ACTD & Country Specific format).• To prepare and dispatch variation application of registered products.• Co-ordination and collection of necessary information/data from FnD, QA, QC and Store department for registration requirement.• Responsible to Review of GMP documents like Change Control etc. • To prepare Summary of Product characteristics and Package Insert as per country requirement.• To review Artwork of product as per country requirement.• To collect and provide necessary information and data for tender.• Maintain record of FDA and regulatory submission.• Collection of various pharmacological, pre-clinical, toxicological, Clinical information of molecules.• Handling the regulatory activities for licensing activities i.e. Certificate of Pharmaceutical Product (COPP), Product Permission (PP), FSC, Approval of Technical Person, Manufacturing License etc.• Regulatory compliance/audit related work.

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  Shree S. K. Patel College Of Pharmaceutical Education & Research, Kherva,Mehsana.

  Quality Assurance