DRA cum R&D Head:*For DRA department my key responsibilities are:•Taking approvals from CDSCO/SFDA for new additional items’ test licenses for Technology Transfer. •In Abha Biotechnology I am leading a team (having 8 persons) preparing Dossiers (CTD/ACTD/eCTD, PIF, Short dossier for cosmetics & Cosmaceuticals, DMF, BE Study/Bio-waiver) for Pharmaceutical Products / Nutraceutical / Cosmaceuticals/Herbal Product Registration in regulated Market.•Handling queries from respective… Show more DRA cum R&D Head:*For DRA department my key responsibilities are:•Taking approvals from CDSCO/SFDA for new additional items’ test licenses for Technology Transfer. •In Abha Biotechnology I am leading a team (having 8 persons) preparing Dossiers (CTD/ACTD/eCTD, PIF, Short dossier for cosmetics & Cosmaceuticals, DMF, BE Study/Bio-waiver) for Pharmaceutical Products / Nutraceutical / Cosmaceuticals/Herbal Product Registration in regulated Market.•Handling queries from respective Ministry of health in which we register the product of clients along with the solution for successful registration.•Responsible for preparation and review of PSUR/PIL/RMP/Artwork designing as per country guidelines. Preparing and modifying VMP/AMV/PDR/CMC part of dossier.•Providing guidance to various clients in plant setup (Dosage forms/API/Herbal/ Nutraceuticals) responsible for layout designing and file preparation for getting manufacturing license along with technology transfer of manufactured products/ additional items.*For R&D department my key responsibilities are:•Pilot Batch Trials to develop new products (Q&Q, MFR, PDR) for client/ Technology Transfer.•Provide solution for problem arises in the manufactured/ manufacturing batch with gap analysis like Dissolution, Disintegration and Friability etc.in any dosage form). • Providing guidance to Ph.D./M.Pharmacy research scholars, doing research/ thesis writing from our F&D Facilities. Show less

As DRA Manager: (Lead 8 DRA Executive and officers team)* External Application Section, Oral Liquid section Setup: Monitor the site installation work, Design and modify layout via AutoCAD in compliance of Man & Material movement.* Prepare documents file for new manufacturing license on Form 25 & Form 28 along with new additional section file and put up to state drug office.* Handel ACTD, CTD and eCTD Dossier fillings and query raised by respective MOH.* BE study NOC from CDSCO… Show more As DRA Manager: (Lead 8 DRA Executive and officers team)* External Application Section, Oral Liquid section Setup: Monitor the site installation work, Design and modify layout via AutoCAD in compliance of Man & Material movement.* Prepare documents file for new manufacturing license on Form 25 & Form 28 along with new additional section file and put up to state drug office.* Handel ACTD, CTD and eCTD Dossier fillings and query raised by respective MOH.* BE study NOC from CDSCO and involving in BE Study with CRO in manner of %age of chromatogram added as per country specific guidelines.* Handling of query/Letters received from Drug Inspector/NPPA/NDPS etc.As R&D Manager: ( Lead 3 R&D officers team)* Took approval for existing marketing sample from drug office and develop similar product for addition in company basket.* Handling of deviations raised during manufacturing of Tablet, Capsule, Dry Syrup, Oral Liquid and External Applications (Disintegration problem/Dissolution problem/ Precipitation etc.) Show less

 Dossier preparation for registration of products with regulatory bodies of various countries & Responsible for Preparation of CMC Part (Module 3).  Nutraceuticals Dossiers preparation, Product development with FSSAI compliance. Responsible for Preparation & Review of Dossiers in CTD, ACTD formats & Short dossiers for Cosmetics (PIF, Product Information file). Work for Registration of product GCC (Gulf Cooperation Council), Africa, Non-regulated market and ROW… Show more  Dossier preparation for registration of products with regulatory bodies of various countries & Responsible for Preparation of CMC Part (Module 3).  Nutraceuticals Dossiers preparation, Product development with FSSAI compliance. Responsible for Preparation & Review of Dossiers in CTD, ACTD formats & Short dossiers for Cosmetics (PIF, Product Information file). Work for Registration of product GCC (Gulf Cooperation Council), Africa, Non-regulated market and ROW Countries. Responsible for Review of Technical documents :(RM Specification, VMP, AMV, SMF, DMF, BMR, Analytical Method validation Protocol/report, Stability study protocol/ report. Process validation protocol and report.) Reviewing & approving the packing material artwork as per Respective Country MOH requirement for export purpose. For domestic CDSCO & FSSAI (Label, Carton, Foil and Leaflet). BE study by CDSCO approved BA/BE Centres. Third Party Audit for client and GMP training programme. Show less

As R&D officer: *Design and Development of External Application (Cream/Lotion/Gel/Liniments/Peels) and Oral Solid Dosage Forms (Nutraceutical Tablets and Capsules)* Prepare MFR ( Master Formula Records).* Prepare Q&Q ( Qualitative & Quantitative formula) as per developed formulation.* Prepare STS, STP, COA of pilot batches.* Scale up of pilot batches with production department.As DRA officer:*Prepare DMF (Drug Master File) for Dossier compilation.*Prepare and… Show more As R&D officer: *Design and Development of External Application (Cream/Lotion/Gel/Liniments/Peels) and Oral Solid Dosage Forms (Nutraceutical Tablets and Capsules)* Prepare MFR ( Master Formula Records).* Prepare Q&Q ( Qualitative & Quantitative formula) as per developed formulation.* Prepare STS, STP, COA of pilot batches.* Scale up of pilot batches with production department.As DRA officer:*Prepare DMF (Drug Master File) for Dossier compilation.*Prepare and modify technical documents as per dossier requirements.* Responsible for preparation of quality part (CMC part) of dossier. Show less

Design and Development of novel delayed drug delivery systems of DMARD's to treat early morning peak symptoms of rheumactic arthritis.

DRUG MASTER FILE, JDMF, CTD, ASMF, ANVISA DRUG SUBSTANCE REGISTRATION ANDQA DOCUMENTATION