Achieving International Regulatory Compliance Across 14 Global Markets

How Agnivesh provided end-to-end technical dossier compilation, US FDA 21 CFR Part 111 documentation, and EU novel food compliance, facilitating simultaneous multi-market commercial launch through our Nutraceutical Export Services and certified manufacturing facilities.

14 Countries
100%
Dossier
Pass

The Challenge

Exporting dietary supplements and functional formulations internationally requires navigating an intricate web of differing jurisdictional requirements: US FDA dietary supplement notifications, EU EFSA upper limit directives, UK MHRA notifications, and TGA complementary medicine listings in Australia.

The brand sought to launch a flagship cognitive and energy botanical stack across 14 sovereign jurisdictions within a strict 6-month launch window, but faced fragmented regulatory roadblocks and labeling disparities.

14 Countries

Simultaneous cross-border market entry achieved within 5 months

100% Approval

First-time regulatory dossier submissions without rejection

Zero Customs Delays

Pre-cleared port documentation eliminating cargo demurrage

45 Days

Accelerated full technical dossier preparation timeline

Our Technical Solution

Agnivesh Regulatory Affairs team orchestrated an integrated export compliance pathway:

Standardized Common Technical Dossiers (CTD): Compiled exhaustive dossiers including Master Formula Records (MFR), Batch Manufacturing Records (BMR), and validated analytical test procedures for each active constituent.
Localized Compliant Labeling: Adjusted botanical naming to International Nomenclature of Cosmetic Ingredients (INCI) and European botanical nomenclature, aligning health claims with EFSA Article 13.1 guidelines.
Pre-Shipment Certificate of Analysis (CoA) & Free Sale Certificates: Issued government-attested Certificates of Free Sale (CFS), non-GMO certificates, and heavy metal & pesticide residue screens.

“With Agnivesh handling our regulatory compliance and export documentation, we were able to launch globally without a single port detention or labeling dispute.”

The Commercial Impact

The brand achieved an immediate $3.2M increase in international top-line revenue within the first two quarters following their synchronized global release, establishing themselves as a credible multinational supplement player.

Planning an International Supplement Launch?

Tap into our specialized export desk for CTD dossiers, US FDA compliance, EU registration, and customs clearance support.