Product Classification & Applicability
Review intended use, product particulars and activity to map regulatory questions.
LICENSING & REGISTRATIONS · FOOD & CONSUMER
CDSCO Registration, Licensing & Regulatory Advisory
Navigating Healthcare Regulations. Supporting Product Compliance. Enabling Responsible Market Access.
OUR SERVICES FOR CDSCO
CDSCO and healthcare regulatory services
Support for product classification, licensing, applications, label review and ongoing regulatory obligations.
Drug Regulatory Advisory
Coordinate relevant drug import, manufacturing and regulatory workstreams.
Medical Device Licensing
Review medical device classification and applicable licence requirements.
Cosmetics Regulatory Advisory
Assess cosmetics registration, import and compliance requirements.
Import Licence & Registration Support
Organise product and importer documentation for relevant applications.
Manufacturing Licence Coordination
Coordinate licensing information for manufacturing operations.
Technical Documentation Review
Organise product and technical materials for regulatory review.
Regulatory Application Assistance
Support application preparation and submission coordination.
Product Labelling & Claims Review
Review applicable label declarations and product claims.
Licence Amendments & Renewal
Plan amendments and renewal work around current permissions.
Inspection & Compliance Support
Organise records and coordinate inspection-related follow-up.
Regulatory Notices & Legal Remedies
Structure records and coordinate the response with appropriate professionals.
KEY BENEFITS
Why plan healthcare product compliance early?
CDSCO-related pathways depend on whether a product is a drug, medical device or cosmetic, its intended use and the activity proposed in India. We help organise classification, licensing and application workstreams around verified technical information.
Considered for your next chapter.
Statutory authorisation
Identify applicable permissions before regulated products enter the market.
Product safety and quality
Coordinate regulatory records with quality and technical information.
Regulatory clarity
Map the product category, activity and responsible authority workstreams.
Market access support
Organise documentation and responsibilities for domestic or import activity.
Reduced compliance risk
Identify requirements and changes early in product planning.
Continuing advisory support
Review amendments, renewals and post-market obligations.
BUSINESS STRUCTURE & TAXATION ASPECTS
Regulated product categories
CDSCO-related pathways depend on whether a product is a drug, medical device or cosmetic, its intended use and the activity proposed in India. We help organise classification, licensing and application workstreams around verified technical information.
- Pharmaceutical products
Review product status, manufacturing or import activity and relevant licence routes.
- Medical devices
Assess intended purpose, risk classification and applicable regulatory pathway.
- Cosmetics
Review product composition, claims, import or manufacturing role and documentation.
- Clinical research and trials
Identify the approval and specialist coordination questions for the proposed activity.
- Product lifecycle
Track changes, conditions and continuing compliance after market entry.
Clarity for what comes next.
COMPARATIVE ANALYSIS
CDSCO licence types and applicability
The appropriate route depends on product classification, activity, risk and current regulatory requirements.
| Features | Product / activity | Regulatory focus | Typical pathway |
|---|---|---|---|
| Manufacturing licence | Drugs, medical devices or cosmetics | Product- and activity-specific licence coordination | |
| Import licence | Regulated products brought into India | Product documentation and importer application | |
| Cosmetics registration | Imported cosmetics and product particulars | Registration and supporting information review | |
| Medical device licence | Device class and intended purpose | Applicable permission and technical evidence | |
| Clinical trial / research | Study type, product and participants | Approval and ethics review coordination as applicable |
Use this overview as a starting point for advice on the proposed structure and circumstances.
REGISTRATION & LICENSING PROCESS
A considered regulatory route for healthcare products
Define the product and activity first, then coordinate the applicable technical, application and compliance workstreams.
Consultation & product assessment
Collect product details, intended use, classification and business roles.
Regulatory classification
Identify applicable product category, authority and permission questions.
Document preparation
Organise technical, quality, entity and product documentation.
Application submission
Coordinate the relevant CDSCO or state-level application process.
Scrutiny & inspection
Track authority questions and coordinate appropriate technical responses.
Licence issuance & compliance
Maintain permissions, records and post-market responsibilities.
DOCUMENTS & REQUIREMENTS
Documents generally required
The evidence required varies by product category, licence route and business role.
- Business constitution documents
- Authorised signatory details
- Product specifications and composition
- Manufacturing or import details
- Quality management certificates
- Product labels and artwork
- Test reports and clinical data, where relevant
- Existing licences and regulatory correspondence
PROFESSIONAL FEES & ADVISORY PACKAGES
Practical support for your next step
Choose a starting advisory scope. Final fees depend on the activity, locations, products and documentation involved.
Basic Advisory
₹4,999- Product classification
- Applicability review
- Document checklist
- Basic advisory note
Comprehensive Advisory
₹14,999- Detailed documentation review
- Application assistance
- Status follow-up
- Initial compliance guidance
Custom Quote
For multi-product portfolios, technical dossiers or complex regulatory pathways.
Get a QuoteProfessional advisory fees shown are indicative and exclusive of applicable taxes and government charges. Registration outcomes and timelines depend on the relevant authority and complete information.
FREQUENTLY ASKED QUESTIONS
Browse all FAQs A few useful answers
Answers to common questions about CDSCO pathways, product classification and healthcare compliance.
How do we know whether a product is a drug, cosmetic or medical device?
Can an existing licence cover a new product?
Can you prepare technical or clinical evidence?
Are CDSCO approvals guaranteed within a fixed timeline?
TESTIMONIALS
Clear advice. Practical direction.
Perspectives shared with permission by clients of our advisory teams.
Astronis Global brought clarity and commercial focus to a complex restructuring exercise. Their advice was practical, timely and easy for our leadership team to act on.
The team understood our regulatory requirements quickly and helped us move forward with confidence. We valued their responsiveness and disciplined follow-through.
Astronis Global provided dependable support across multiple registrations and approvals. Their communication was clear, structured and consistently professional.
INSIGHTS & EVENTS
View all insights Latest Articles, Updates and Events
Medical Devices · 18 Jun 2025
CDSCO Medical Device Licensing in India: Class A, B, C & D Explained
Read insight
Pharmaceuticals · 07 May 2025
Drug Import & Manufacturing Licensing: Key Regulatory Requirements
Read insight
Cosmetics · 12 Apr 2025
Cosmetics Registration in India: Labelling and Compliance Essentials
Read insightKNOWLEDGE CENTRE
Guides, checklists and templates
Explore resources to help organise your formation planning.
YOUR NEXT CHAPTER STARTS HERE
Plan a responsible route to healthcare market access.
Discuss product classification, CDSCO licensing and the regulatory documentation relevant to your business.
Schedule a Consultation