Jothi K Email & Phone Number

Preparing the Drug license & product endorsement Artwork check and approval.Ensuring the documentation as per ISO and GMP requirement.Preparation of dossier for pharmaceutical Products for Indian and International Markets.Preparation of Wholesale licensePreparation of Certificate of Pharmaceutical Products (COPP) (as per WHO GMP guidelines) Preparation of Free sale certificate as per schedule DPreparation of Form 10 License (Import License) Preparation of Form 29 for Test License central drugs standard control organization test license division.Registration of pharmaceuticals in Dubai (UAE)Review of documents required for regulatory agencies (Viz: Analytical Method Validation, Stability Data, Process Validation protocol and Reports)Review of documents quality and analytical data as per the pharmacopeia, specification, MOA, finished product data for the purpose of compilation of the dossier.Preparation and Review of Standard Operating Procedures.Srilanka plant registration and product registration as per CDDA Guidelines.DUBAI plant registration and product registration as per Ministry of Health (Form 1 & Form 2 for Tablet & Liquid).Preparation of tender documents to Export countries.Also handled Internal & External audits PeriodicallyDMF Review