MANUFACTURING OF COLD PRESSED EDIBLE OILS

Manufacturing sites and Product registration in ASEAN, AFRICAN, LATAM and CIS countries.

-Mfg Site registration in ASEAN countries as per PIC/S guidelines. Successfully registered 2 Indian manufacturing sites in Thai FDA.-Dossier compilation for South East Asian market (Thailand, Philippines, Indonesia, Malaysia) in ACTD format-Dossier compilation for Latin American countries such as Panama and Dominican republic-Dossier compilation for CIS countries such as Kazakhstan in CTD format-Timely response to the deficiencies/ queries raised by the regulatory agencies or customers-Project Planning, Regulatory Analysis and intelligence, Regulatory Strategies along with risk assessment and Product life Cycle Management-Reviewing and submitting technical documents like BMRs, BPRs, and Validation data, required to be submitted in the dossiers.-Regulatory investigations in new market such as African, Latin American and appointing regulatory consultants in respective countries.-Coordination with QA,QC, R&D, Packing, Production Departments for technical data-Proper co-ordination/monitoring Loan license sites for generating regulatory data such as Process validation, Stability etc. -Developing artworks In-house for exports and getting it approved from Health ministries of various countries (in the dossiers)-Planning routine and process validation batches at loan licenses sites and keeping follow-up on the data which is required in the dossiers. -Updating and filing variations for the registered productsDomestic regulatory - FDA, MS-Liasoning with MAH FDA for issuing various licenses like Selling/distribution license, Loan license, additional product licenses, Test licenses etc through online portal.-Applying and issuing WHO-GMP / COPP online on FDA’s websiteCDSCO / DCGI-Applying and issuing Import Licenses for the APIs-Applying and issuing Test Licenses to import reference products-Applying and issuing Export NOCs from CDSCO’s North zone and west zone offices

-Compiling dossiers and arranging samples for South East Asian, Latin American and African countries as per MOH’s requirements for product registrations (Vietnam, Cambodia, Myanmar, Philippines, Srilanka, Thailand, Malaysia, Panama, Venezuela, Kenya and Zambia).-Preparing and issuing registration documents such as COPP’s, FSC’s, FSCC’s etc, required for product registration.-Reviewing and submitting technical documents like BMR’s, BPR’s, and Validation data, along with dossiers.-Submitted ACTD in Malaysia for tablet formulation.-Updating registration status (Product wise and country wise) and submitting Re-registration dossiers as and when required.-Proper co-ordination with R&D and Production dept for getting data required in dossiers.-Proper co-ordination with Marketing Dept and submitting dossiers as per their Scheduled plan and getting product registrations within timeframe.-Replying to various queries within timeframe.

-Maintenance of Goldshield’s Product Licences in Europe (UK & Ireland)-Application for Variations to current Product Licences-Renewals for current Product Licences-Label and leaflet variations

Regulatory Affairs-International-Preparation of Dossiers for various countries as per requirement by Ministry of health to give complete information about the drugs.-Sending samples as per the requirement of Ministry of Health.-Surfing Net for collecting information required for dossiers.-Replying queries and providing corrected/additional data as and when required.-Preparing and issuing registration documents such as COPP’s, FSC’s, FSCC’s etc, required for product registration.Regulatory Affairs-India-Import Registrations: -Preparation & submission of the Technical Dossiers for Import Registrations of Manufacturing Sites, Finished Formulations and Active Substances in compliance with the regulations prescribed by the Office of DCGI, New DelhiImport Licences: -Preparation & submission of Application for Import Licences.-Updating and filing variations for the registered products.-Re-registration of existing products

-Preparation of Dossiers for various countries as per requirement by Ministry of health.-Preparation of Dossiers as per company’s requirements as per CTD format.