Regulatory Consulting Services India — CDSCO Compliance & Regulatory Affairs
Specialist regulatory affairs consulting services for India — covering CDSCO (Central Drugs Standard Control Organisation) requirements and all major regulatory frameworks.
Regulatory consulting services India companies and international manufacturers need must combine in-depth knowledge of CDSCO (Central Drugs Standard Control Organisation) requirements with practical experience in Indian regulatory submissions, drug registration, medical device licensing, and clinical trial approvals. India’s regulatory landscape has undergone significant transformation in recent years — with the introduction of the Medical Devices Rules 2017, New Drugs and Clinical Trials Rules 2019, and ongoing CDSCO capacity building. At RABT Global, our CDSCO regulatory consulting services are delivered by specialists with direct experience in Indian regulatory submissions across pharmaceuticals and medical devices.
Regulations & Requirements — India
- New Drugs and Clinical Trials Rules 2019
- Medical Devices Rules 2017 (as amended)
- Drugs and Cosmetics Act 1940 (as amended)
- CDSCO guidance documents and circulars
- Schedule M GMP requirements
Our India Regulatory Consulting Services
CDSCO submission consulting
Form 44 drug registration, NDA India, imported drug licensing
Medical device regulatory services India
Class A–D device registration (MD-14 to MD-17)
Pharmaceutical regulatory consulting India
generic drug registration, clinical trial applications
Indian regulatory compliance services
Schedule M GMP, pharmacovigilance
Life sciences regulatory consulting India
regulatory strategy for Indian market entry
CDSCO regulatory consulting services
clinical trial applications (CTA/IND India)
Regulatory Consulting Services in India
RABT Global provides specialist regulatory consulting services in India — covering pharmaceutical drug registration, medical device regulatory compliance, clinical trial applications, and ongoing regulatory lifecycle management under CDSCO (Central Drugs Standard Control Organisation) regulatory requirements. Our India regulatory consulting team combines in-country regulatory experience with global life sciences expertise to deliver effective, efficient regulatory programmes for every client.
India Regulatory Consulting — FAQs
A: Foreign pharmaceutical manufacturers wishing to market their products in India must obtain registration from CDSCO. The process involves submission of a Form 44 application with comprehensive technical dossier (clinical, quality, and non-clinical data), site inspection (for new applicants), and CDSCO review. RABT Global’s CDSCO regulatory consulting services manage the complete process, including dossier preparation, liaison with CDSCO, and inspection support.
A: Medical devices in India are regulated under the Medical Devices Rules 2017 (amended) under CDSCO. Devices are classified into Class A (lowest risk) to Class D (highest risk). Import licences are required for all Class B, C, and D devices, and for Class A devices that are not self-certified. RABT Global provides medical device regulatory services India-wide, covering all device classes and registration categories.
A: RABT Global brings specialist CDSCO (Central Drugs Standard Control Organisation) regulatory expertise combined with a global regulatory perspective. Our India regulatory consulting services are delivered by dedicated in-country regulatory specialists — ensuring accurate, up-to-date guidance on all aspects of India regulatory requirements for pharmaceutical and medical device companies.
Navigate India Regulatory Requirements with Confidence
Expert regulatory consulting services for India. CDSCO (Central Drugs Standard Control Organisation) compliance. Market access. Delivered by RABT Global’s specialist India regulatory team.