Pharma DMFs Compilation, Review and Filing in Various Regulatory Authorities and Marketing Procedures (CP/DCP/MRP/NA) i.e., Europe, EDQM, USFDA, TPD-Canada and TGA-Australia with Accordance to Filing Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries. USDMF: United States Drug Master File, (Open and closed part). Certificate of Suitability (CEP-COS) of EDQM. eCTD Compilation. DMF-Life cycle management. Technical Packages for Pharma Intermediates. DMF review as per ICH guidance. Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Interme...

Chemical Process and Catalyst Technology Evaluation, Licensing, Patent Analysis, Sales and Marketing, Mergers & Acquisitions, Market Studies, & Strategic PlanningCatalyst and Process Technologies ProductionAcetic acid and acetic anhydride.1,4-butanediol, tetrahydrofuran and gamma butyrolactone.n-butanol and isobutanol, n-butyraldehyde, isobutyraldehyde, 2-ethylhexanol.Carbon dioxide and carbon monoxide.Ethylene, ethylene oxide, ethylene glycols, ethylene glycol ethers, ethanolamines, ethyleneamines, ethoxylates, and polyetherpolyols..Formaldehyde and formic acid.Hydrogen and hydrogen peroxide.Maleic anhydride and phthalic anhydride.Methyl...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...