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Regulatory Affairs
Food Regulatory Affairs
We provide regulatory expert support, strategic consulting solutions for Food, Nutraceuticals, and animal feed products across the globe. It is necessary to have a right regulatory partner to extend your business in domestic and international market. We help our clients in ever changing regulatory landscape with scientific and technical data to enter into global markets
We have expert team to help our client in FSSAI licensing and registration process, we always scrutinize each application before submitting to the certifying bodies. We work for manufacturers, traders, retailers in licensing and registration
It is important to be complaint with FSSAI in each every step from manufacturing to selling product consumer. We help our clients to check for FSSAI compliance and categorizing the products and labeling compliance
Importing of food in India, involves lot of regulation and it requires clear understanding of the regulatory requirement and recent, trends, challenges. We ensure right way of importing goods in different commodities as an Importing licensing holder
Pharma Regulatory Affairs
Our lifesciences regulatory strategic consulting and operational services support to your product or device in local and global markets. We work for both highly regulated markets and rest of the world markets (ROW) in Pharmaceuticals, Cosmetics, Medical Devices landscape.
We help our pharmaceutical manufacturing clients to overcome the barriers in dossier filings for various drug products for NDA, ANDA. We assist clients in getting the manufacturing license, Test License, Export NOC, Wholesale license, BE NOC for Exports, Pre-Marketing and Post marketing regulatory services like Import License, Product registration certificates, Re-registrations, shelf-life extensions
We have full eCTD publication capabilities, including eCTD conversion of paper and publishing of eCTD submissions. We write, review dossier as per European CTD/ASEAN CTD/ non-CTD (Country specific), expert in preparing DMF and ANDA dossier Module-I to V. We have expert team to prepare and review of packaging material (Labeling) as per the intended regulatory market
We assist Institutional Ethics Committees/Independent Ethics Committees to get the regulatory registration, re-registration, meeting management, handling regulatory queries and training