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Market Authorisation
Regulated products such as Pharmaceuticals, Medical Devices & IVDs, Cosmetics, Food & Nutritionals that are proposed to be Imported,Manufactured, Tested, Stored, Distributed have to be registered with a designated regulatory agency before they can be marketed or sold in India. Various designated regulatory agencies such as CDSCO (for medicines, cosmetics), FSSAI (for food & nutritionals) etc., follow specific registration procedures based on the nature of products being registered.
In general, the Product Registration process leading to Market Authorisation(based on which the product can be freely marketed in India) can be initiated only through aManufacturer’s Legal Business in India, or their Subsidiary or through an Importer or an India based Authorised Agent.
Vyomus Consulting provides efficient and effective Product Registration Services and Authorized Agent Services to all categories of regulated products indicated above. An end-to-end service offering that will help you import and market your products in India efficiently through faster product approvals leading to enhanced access to Markets and Opportunities.
Product Category -> Regulatory Agency -> Appropriate Application Procedure -> Regulatory Review -> Query & Resolution -> Market Authorisation -> Market in India.
Following are some product categories regulated by :
- CDSCO (Central Drugs Standard Control Organization) :Pharmaceuticals, Medical Devices & IVDs, Cosmetics, Biologics & Biosimilars, rDNA products, Phyto Pharmaceuticals, Blood &Blood Products,Veterinary products, Ayurvedic products, Vaccines,Generics, Fixed Dose Combinations.
- FSSAI(The Food Safety and Standards Authority of India) :Food, Health supplements, Nutraceuticals, Foods for special dietary use, Foods for special medical purpose, Nutritional ingredients, Genetically modified food, Food with prebiotics, Food with probiotics, Organic Foods, Functional food, Proprietary food, Novel food.
Industry focus :Pharmaceuticals, Medical Devices, Cosmetics & Wellnes, Food & Nutrition.
- Prepare, review, submit, obtain and maintain Market Authorisations for the following medicinal products at CDSCO : Pharmaceuticals, Medical Devices & IVDs, Cosmetics, Biologics & Biosimilars, rDNA products, Phyto Pharmaceuticals, Blood & Blood Products, Veterinary products, Ayurvedic products, Vaccines, Generics, Fixed Dose Combinations etc.,
- Prepare, review, submit, obtain and maintain Market Authorisations for the following food products at FSSAI : Food, Health supplements, Nutraceuticals, Foods for special dietary use, Foods for special medical purpose, Nutritional ingredients, Genetically modified food, Food with prebiotics, Food with probiotics, Organic Foods, Functional food, Proprietary food, Novel foods etc.,.
- Act as your India Regulatory Department for maintaining required licenses and provide post authorisation support such as Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities.
- Act as your Authorised Agent in India.
