Pharma Regulatory Services

Labelling Support Services

Ensure Every Label is Regulatory Compliant Before It Reaches the Market. Comprehensive Label, Artwork and Packaging Compliance Reviews for Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, Food Products and Healthcare Products. Prevent costly recalls, import detentions, product seizures, misbranding actions, and regulatory observations through expert review of labels, cartons, package inserts, promotional claims, QR codes, and artwork against applicable Indian regulatory requirements.

100% Pre-Market Label Audit
Multi-Sector Regulatory Review
Fast Artwork Compliance Turnaround
Zero Misbranding Risk

Product packaging is often the first aspect reviewed during regulatory inspections and market surveillance. Even minor labelling deficiencies can result in product recalls, import delays, licence actions, misbranding proceedings, or legal penalties. Our experts conduct comprehensive artwork and label compliance reviews against the Drugs & Cosmetics Act and Rules, Medical Device Rules, Cosmetics Rules, Legal Metrology (Packaged Commodities) Rules, Food Safety and Standards Regulations, DPCO requirements, and other applicable regulations to ensure your products reach the market with confidence.

What we deliver

  • Pharmaceutical Label Compliance — Primary and secondary label review for domestic and export purpose, Package insert review.
  • Medical Device Labelling — MDR 2017 compliance, BIS requirements, Device classification declarations, Sterility statements, CE/FDA compatibility review (where applicable), Legal Metrology Compliance.
  • Cosmetics Compliance — Ingredient declarations, INCI nomenclature, Warnings, Batch coding, Import labelling, Shelf-life declarations, Legal Metrology Compliance.
  • Food & Nutraceutical Compliance — FSSAI declarations, Nutritional information, Health claims, Allergen declarations, Vegetarian/Non-Vegetarian logo, Licence details, Legal Metrology Compliance.
  • Legal Metrology Review — Net quantity, MRP, Manufacturer details, Customer care information, Month & year, Country of origin, Mandatory declarations.
  • Regulatory Claim Review — Therapeutic claims, Promotional claims, Disease claims, Comparative claims, Mandatory caution statements.
  • DPCO Review — Price declarations, NPPA compliance.
  • Import Label Compliance — Over-stickering, Customs compliance, CDSCO declarations.

Our Approach

01

Artwork Collection

Receive labels, cartons, package inserts, artworks, and applicable product details.

02

Regulatory Compliance Review

Review against applicable regulations, identify deficiencies, and assess regulatory risks.

03

Compliance Report

Provide a clause-wise report with required corrections and recommendations.

04

Final Verification

Review revised artwork and confirm readiness before commercial printing or product launch.

Who this is for

Pharmaceutical ManufacturersMedical Device ManufacturersCosmetics ManufacturersNutraceutical CompaniesFood BusinessesImportersExportersContract ManufacturersMarketing CompaniesPackaging Development TeamsRegulatory Affairs DepartmentsBrand ManagersArtwork Agencies

Regulations We Cover

Drugs & Cosmetics RulesMedical Device RulesCosmetics RulesLegal Metrology ActPackaged Commodities RulesFood Safety & Standards RegulationsDPCO

What We Check During Every Review

Generic name
Brand name
Strength
Dosage form
Composition
Schedule warning
Storage conditions
Licence number
Manufacturing details
MRP
Batch No.
Manufacturing date
Expiry
Barcode
QR Code
Legal Metrology declarations
FSSAI declarations
Importer details
UDI
Caution statements
Prescription warnings

Frequently asked questions

Let's Talk

Every Label Represents Your Compliance

Your product label is more than a marketing tool—it is a legal document that demonstrates compliance with applicable regulatory requirements. A single labelling error can lead to import delays, product recalls, misbranding actions, financial penalties, or damage to your brand reputation. At Vaayath, we combine regulatory expertise, practical industry experience, and detailed compliance knowledge to ensure your labels, cartons, package inserts, and artworks meet all applicable legal and regulatory requirements before they reach the market. Review your artwork before regulators do. Partner with Vaayath for accurate, reliable, and compliant labelling solutions.