Regulatory & Compliance Advisory
Navigating Regulatory Requirements with Confidence
Regulatory compliance is critical for the successful development, registration, manufacturing, marketing, export, and distribution of healthcare and wellness products. Herbal Consultants helps businesses navigate complex regulatory requirements across India and international markets, ensuring products meet applicable standards and reach the market efficiently. Whether you are launching a new product, establishing a manufacturing facility, entering a new market, or expanding globally, our regulatory experts provide practical guidance and end-to-end support throughout the compliance journey.
Our Legal & Regulatory Services
Product Registrations & Approvals
Support for product licenses, registrations, notifications, approvals, and regulatory submissions across herbal, Ayurvedic, nutraceutical, dietary supplement, food, cosmetic, and healthcare product categories.
Manufacturing Licenses & Facility Approvals
Assistance with manufacturing licenses, GMP approvals, industrial permissions, local authority approvals, Fire NOCs, Pollution Control Board approvals, factory compliance requirements, and operational permissions.
GMP & Certification Support
Guidance and support for WHO-GMP, USFDA-GMP, EU-GMP, MHRA-GMP, ANVISA-GMP, FSSAI, ISO, Halal, Kosher, NSF, Organic, and other national and international certifications.
Label & Claim Compliance
Review and development of compliant product labels, Supplement Facts panels, Nutrition Facts panels, health claims, structure/function claims, marketing materials, and advertising communications.
Formula Review & Classification
Scientific and regulatory assessment of formulations to determine product classification, applicable regulations, compliance requirements, and registration pathways.
Food Regulatory Affairs
Support for food classification, novel food assessments, GRAS evaluations, food label compliance, nutrition declarations, health claim reviews, and food regulatory submissions.
Dietary Supplements & Nutraceuticals
Guidance on DSHEA compliance, NDI (New Dietary Ingredients), ODI (Old Dietary Ingredients), FDA notifications, FSSAI compliance, product testing reviews, and adverse event reporting requirements.
Cosmetic Regulatory Affairs
Ingredient reviews, cosmetic label compliance, claim reviews, cosmetic notifications, GMP guidance, and regulatory documentation for cosmetic and personal care products.
OTC & Healthcare Product Support
Assistance with product classification, regulatory pathway determination, product notifications, compliant labeling, and documentation requirements for OTC healthcare products.
Regulatory Documentation
Preparation and review of technical dossiers, CTD dossiers, product information files, technical files, registration documents, scientific substantiation reports, and supporting regulatory submissions.
Regulatory Audits & Compliance
Evaluation of products, facilities, systems, documentation, and quality processes to identify compliance gaps and implement corrective actions.
Regulatory Liaison & Representation
Coordination with regulatory authorities and assistance in responding to government notices, queries, observations, and compliance-related communications.
Why Choose Herbal Consultants?
Extensive regulatory expertise
Multi-country compliance experience
Strong understanding of healthcare regulations
Expertise across food, nutraceutical, cosmetic, herbal, and healthcare sectors
Practical and commercially focused guidance
End-to-end regulatory support
Strong documentation and compliance capabilities
Reduced compliance and market-entry risks