Navigating international regulatory frameworks is critical for product registration, consumer safety, and seamless market entry. Zeon Lifesciences provides end-to-end regulatory support back-backed by 38+ years of expertise, ensuring your formulations, labels, and dossiers satisfy global food safety and dietary supplement authorities.
Complete assistance in procuring State and Central FSSAI licenses, facility audits, product approval filings, and overseas regulatory compliance dossiers for export expansion.
Rigorous label review verifying statutory panels, allergen warnings, ingredient nomenclature, serving sizes, and country-specific formatting under US FDA, EU, and FSSAI norms.
Compiling scientific literature, clinical safety dossiers, and analytical data to validate health, structure-function, and nutritional claims without consumer deception.
Analyzing raw active ingredients, excipients, and botanical markers to classify products under correct standard regulatory categories (FSDU, FSMP, Probiotics, Prebiotics).
Ensuring vitamin and mineral concentrations adhere strictly to ICMR Recommended Dietary Allowances and destination-market upper tolerable intake thresholds.
Preparation of Certificate of Free Sale (CFS), Certificate of Analysis (COA), Stability Reports, BSE/TSE declarations, and heavy metal/microbiology validation packages.
Our regulatory affairs division monitors evolving legislation across major trade jurisdictions to keep your product lines fully compliant and commercialized without operational delays.
Key regulatory insights answered by our in-house compliance specialists to assist international procurement and brand management teams.
For Indian market distribution, Food Business Operators (FBOs) require an FSSAI License (State or Central based on turnover). For global distribution, products require US FDA facility registration, FSSC 22000 / GMP certifications, Certificates of Free Sale (CFS), and technical product registration dossiers aligned with destination country laws.
FSSAI certification ensures that food supplements meet mandatory quality, safety, and hygiene thresholds. It guarantees ingredient safety, prevents adulteration, establishes consumer trust, and satisfies legal prerequisites for commercial food trade.
Any commercial entity involved in manufacturing, formulating, packaging, importing, storing, or marketing food supplements must obtain an FSSAI registration or license based on operational scale and annual revenue.
Nutraceuticals are governed under specialized regulatory frameworks (such as FSSAI Health Supplements & Nutraceuticals Regulations in India, US DSHEA guidelines in North America, and EFSA regulations in Europe) regulating active ingredient limits, permissible additives, safety parameters, and label claims.
FSSAI issues three categories of operational licenses: Basic Registration (annual turnover below ₹12 Lakhs), State License (turnover between ₹12 Lakhs and ₹20 Crores), and Central License (turnover exceeding ₹20 Crores or entities engaged in international trade and multi-state operations).
Regulatory oversight enforces standardized disclosure of nutritional info, active potencies, lot batch coding, shelf-life date formatting, statutory allergen declarations, and non-misleading claim statements to safeguard consumer health.
Yes. For domestic Indian distribution, micronutrients cannot exceed the maximum limits defined by ICMR/FSSAI regulatory directives. For export manufacturing, formulation potencies are customized to comply with destination country upper limits.
Every commercialized batch undergoes testing in instrumented QC labs (HPLC, GC, ICP-MS) for active assay content, heavy metals, microbial loads, pesticide residues, and real-time/accelerated stability testing in accordance with ICH guidelines.
Connect with our technical regulatory officers to validate your formula, review packaging artwork, or prepare export registration dossiers.
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