Vilas Nikam
Manager- Regulatory Affairs @Aristo Pharmaceuticals Pvt. Ltd.
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WORK HISTORY
Manager- Regulatory Affairs @Aristo Pharmaceuticals Pvt. Ltd.
Maharashtra, IN
Experienced regulatory professional with expertise in: Market authorization of New Drugs, sND, and FDC (Form CT 21/22) Labeling compliance for Drugs, Nutraceuticals, Health supplements, Food for Special Dietary Use, Food for Medical Purposes, Ayurvedic & Cosmetic products. Licensing activities for Drug and Food products Implementation of Regulatory requirements under the Drugs & Cosmetics Act, FSSR, Ayush Regulations and relevant regulations Pack inserts compliance for Domestic and Export markets Team managementDedicated to ensuring regulatory compliance and smooth market entry for Drug products, Food, Ayurvedic and Cosmetic products.
EDUCATION
SSDJ College of Pharmacy, Chandwad
Master’s Degree, Pharmaceutics (Pharmacy)
Savitribai Phule Pune University
Bachelor of Pharmacy (B.Pharm.), Pharmacy
ABOUT VILAS NIKAM
I\'m Regulatory affairs professional with 8+ years of experience in CDSCO applications (New Drug, SND, FDC, Clinical trials, BA/BE Study, Import & registration etc.), BE study monitoring, Drug licensing (Form CT 10/12/13/16, Form 11), Pack insert & label artworks, FSS regulations, food product labeling of Nutraceuticals, Health supplements, Food for Special Dietary Use (FSDU), Probiotics & Prebiotics. Well versed with regulatory framework & having good knowledge of D&C Act, Food safety & standard (FSS) act & regulations.
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