CDSCO Regulatory Support
End-to-end assistance for registering imported cosmetics in India — from dossier preparation and SUGAM filing to approvals, labeling, and post-approval compliance.
Compliance, Simplified
We translate complex CDSCO rules into a practical, predictable workflow so you can focus on launch.
Complete Dossier Prep
Ingredient review, label vetting, Free Sale Certificates, authorizations, and consolidated documentation.
SUGAM Portal Filing
Online application submission, fee management, deficiency responses, and certificate retrieval.
Label & Claims Review
India-specific labeling, warnings, claims, pack sizes and variants aligned with current norms.
Post-Approval Support
Certificate management, renewals, amendments (variants & sites), and audit readiness.
On-Ground Support
India team for filings and follow-ups, plus our office in Korea for brand/vendor coordination.
How We Work (Step-by-Step)
- Product & Site Scoping: confirm cosmetic category, pack sizes, variants, and manufacturing sites.
- Document Collection & Review: ingredient lists with percentages, manufacturing licenses, Free Sale Certificates, labels/artworks, brand authorizations/POA, and product photos.
- Label & Claims Validation: adapt to India requirements; translate where needed and mark mandatory particulars.
- Dossier Build & SUGAM Filing: prepare forms and annexures, submit online, and manage government fee payments.
- Queries & Clarifications: respond to observations/deficiencies until registration is granted.
- Post-Approval Support: certificate management, change control (variants/sites), renewals, and audit readiness.
Typical Documents We Handle
Core Dossier
Foundation for SUGAM application
- Ingredient/Formula sheet (with % w/w)
- Manufacturing license & details for each site
- Free Sale Certificate / Marketing Authorization from country of origin
- Authorizations: Power of Attorney / Authorization to Indian Representative
- Packing list of sizes/variants with product photos
Labels & Compliance
India-specific particulars
- Artwork with mandatory declarations & warnings
- Importer name & address, MRP format, batch/expiry, net content
- Claims substantiation (where applicable)
- Outer/inner label snapshots for each pack size
Other Certifications
Every product we onboard is screened against internationally accepted safety and quality frameworks. Our goal is simple: predictable compliance, transparent documentation, and trust at scale.
Our Commitment
- Regulatory-compliant sourcing
- Ethical & transparent manufacturing
- Global quality & safety benchmarks
*Where applicable by product/type.
Cosmetic Compliance
- CDSCO Registration (India)
- BIS Standards (where applicable)
- ISO 22716 (Cosmetic GMP)
- EU CPNP / US FDA guidelines
- MSDS, COA & full ingredient transparency
Food Compliance
- FSSAI Central License & Import Clearance (India)
- HACCP & ISO 22000 food safety standards
- FDA / EU food safety regulations (as applicable)
- Organic, Halal & Kosher certifications (product-specific)
Our Korea Office
On-ground Vendor Coordination
Our Korea team works directly with manufacturers for faster document turnaround, artwork updates, and sample management.
Frequently Asked Questions
How long does registration usually take?
Do labels need to be in English?
Can we add new variants later?
What if a product is classified as a device?
Ready to register your brand for India?
Share your product list and we’ll perform a quick feasibility and document gap-check, then propose the most efficient filing plan.
Prefer email? info@makenkorea.com