CDSCO Registration & Consultancy Services
Your Trusted Regulatory Partner
Are you looking for CDSCO registration for your pharmaceutical, medical device, or cosmetic product? We provide comprehensive CDSCO consultancy services to help you navigate the complex regulatory framework seamlessly.
Step 1: Consultation & Eligibility Check
Step 2: Documentation & Application Submission
Step 3: Review & Approval by CDSCO
Step 4: Certificate Issuance & Compliance Maintenance
How to Get CDSCO Certification?
Why Choose Us for CDSCO Registration?
We support an agreed scope of regulatory route review, documentation and application preparation. Provide the product category, intended use, manufacturer and importer details, target activities and existing licences. Requirements, fees and timelines depend on the applicable route. The competent authority decides approval; consultancy cannot guarantee compliance, approval or processing time. Discuss your CDSCO requirements.
Our CDSCO Consultancy Services
1. CDSCO Registration for Medical Devices & Drugs: We assist manufacturers, importers, and distributors in obtaining the necessary CDSCO approvals for medical devices and pharmaceuticals.
2. Import & Manufacturing Licensing: Our team helps secure CDSCO import licenses and manufacturing approvals with a hassle-free process.
3. Cosmetic Product Registration: If you are launching cosmetic products in India, we ensure compliance with CDSCO guidelines and obtain timely approvals.
4. Clinical Trial Approvals: For companies conducting clinical trials, we provide CDSCO clinical trial registration and regulatory support.
5. Post-Market Compliance & Renewals: Stay compliant with CDSCO regulations by ensuring timely renewals and post-market surveillance services.
Get CDSCO Certification with Ease – Expert Regulatory Solutions
Why CDSCO Registration is Important
The required licence, registration or permission depends on the product and activity. CDSCO and state licensing authorities have different responsibilities; there is no single certification route for every drug, cosmetic or medical device. Confirm the current applicable requirements before manufacture, import or sale.
Systematic evaluation and compilation of technical records for regulatory submissions in India.
How does product permission differ from ISO 13485 certification? ISO 13485 certifies a company's quality management system, whereas CDSCO grants explicit regulatory permission to market or import a specific product in India.
Who decides approval and how are costs determined? The regulatory authority holds ultimate decision-making authority over all applications. Government fees, review timelines, and consultancy costs depend entirely on product classification scope and official queries raised.
Product & Role Classification
Applicable Route Identification
Technical Record Review
Establishing the exact product category, medical device risk class, and legal business role as manufacturer or importer.
Determining the regulatory pathway, licensing authority level, and specific application forms mandated for approval.
Auditing device master files, plant master files, test reports, and quality system documentation prior to filing.
Information to Prepare
Document Scope
Filing & Query Support
Required documentation checklists vary significantly based on the specific product category, risk classification, and chosen clearance route. Technical file depth depends on whether the item is an active device, IVD, or pharmaceutical substance.
Applicants must assemble comprehensive information including intended use statements, detailed manufacturer or importer profiles, facility site addresses, full product specifications, existing manufacturing licences, and quality management system records.
Submitting portal dossiers and addressing technical clarification queries raised by the licensing authority.
Quality Systems & Disclaimer
Regulatory timelines and final approvals rest strictly with government authorities. No fixed deadlines or approval guarantees can be provided.
Consulting
Thane based. Mumbai, Pune, India & overseas enquiries welcome.
CONTACT US
Absolute Consultants
Office No. 637, Centura Square, Road No. 27, S. G. Barve Road, Opp. Lanxess House, Wagle Industrial Estate, Thane (W) - 400604
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