The DRIB Consultancy Services Pvt. Ltd. is a fast-growing premier consulting firm specializing in pharma, life sciences and healthcare companies to register and carry out liasoning work with regulatory authorities. Our comprehensive solutions are designed to overcome the challenges within the rapidly evolving global compliances, recruitment solutions and training facilities. The company deploys highly experienced consultants who consistently deliver top quality results for a diverse base of global clients - including pharmaceutical, biotechnology, medical device, cosmetics, food and food supplement firms.
DRIB provides the following service:
DRUGS (PHARMACEUTICALS)
FOR MANUFACTURER
CDSCO Central
• Investigational New Drug (IND)
• New Drug Approval (NDA)
• Subsequent New Drug Approval (SND)
• BE NOC for export
• Special code/Neutral Code for export
• SEC meetings
• Toxicity Studies
• BE Studies
• Clinical Trials
• Medical Writing
State FDA
• Manufacturing License
• Form 29 for Test Batch
• Wholesale License
• Free Sales Certificate
Zonal CDSCO
• Test License
• Export NOC
• Dual NOC
FOR IMPORTER
Pre Marketing
• Authorized Agent/ Registration Holder Support
• Marketing Authorization
• Registration Certificate
• Import License
• Test License
Post Marketing
• Rule 37 Permission
• Re-Registration
• Shelf life Extension
COSMETICS
FOR MANUFACTURER
1. License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31)
2. License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)
3. License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form no. 36)
FOR IMPORTER
1. Authorized agent/ registration holder support
2. Cosmetic registration and approval (Form 42 and Form 43)
3. Amendment in cosmetic registration certificate
4. Re-registration of cosmetic products
FOR LABELING ASSISTANCE
1. Apply for Form 43 and get approval for cosmetic labelling
FOR COSMETIC SAMPLE TESTING
The cosmetic product testing should be performed as per Bureau of Indian Standards (BIS) requirements as well to meet the criteria for imported cosmetic product registration.
FOOD AND NUTRACEUTICALS
Licensing Registration
• Registration
• State License
• Central License
• Advisory Services for FSSAI Regulations Compliance and Inspection
Import Assistance
• FSSAI Compliance
• Categorization of food products/ingredients as per FSSR, 2011 and Proprietary Foods
• FSSAI License
• Product Approval
• IEC Number
FSAAI Compliance
• Labelling & Claim Compliance
• Ingredient Analysis and RDA Analysis
• Formulation Designing
• Product Testing from NABL
• Clinical trials for Claim Support
MEDICAL DEVICES
In India,
Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
