The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across the country.
NUVO Consultancy, your Indian agent and regulatory partner helps you to get through all the regulatory application and approvals, but not limited to Drugs, Cosmetic and medical devices with CDSCO and DCGI office.
We at NUVO, provide full support for all the Drugs, Cosmetics, Medical devices & Biologics
- New Drug Approvals
- FDC Approvals
- Import & Registration
- Global Clinical Trials
- BA/BE NOC
- Post Approvals
- Medical Devices
- Cosmetics Import Registration
- Embassy Attestation
- Nutraceuticals/Food Supplements Approval – FSSAI
- Ethics Committee Registration
- Vaccines & Biological Products
We can act as your authorized Indian agent and representative, and will get sorted all the licensing, filings and approvals needs for easy penetration in to Indian market.
We are with you throughout the approval process from new drugs to generics:
- Suggestions of new drug molecules
- Analysing approval requirements
- Coordinate & compile dossier
- Help connect to trusted BE Centres/CROs
- Pre-screening technical documentsfor errors
- Performingsubmissions (online& offline)
- Assistance inquery replies
- Physical follow-upsat Govt. Departments.
- All-round assistancefor SEC Presentations
- On-time Approval
