Regulatory
"Navigating complex global compliance for health supplements & functional foods"
Jurisdictional regulations vary dramatically — what is a dietary supplement in the US may be a Listed Medicine in Australia or a Novel Food in Europe. Catagens provides expert regulatory pathway mapping to ensure zero-delay compliance.
Scope of Engagement
01 Ingredient permissibility screening and maximum dosage review
02 Health claim validation and label mandatory review
03 Dossier preparation for regulatory submissions (TGA ARTG, FDA NDI/GRAS, FSANZ, FSSAI, NPRA, HSA, TFDA)
04 Safety, toxicology, and efficacy evidence compilation
05 Regulatory advocacy and query response handling
Target Client Profiles
Global Brands entering Australia (TGA Listed Medicines)
Exporting Companies entering Southeast Asia (BPOM, HSA, NPRA, TFDA)
US & European companies filing GRAS or Novel Food notifications
Concrete Deliverables
Regulatory Feasibility & Classification Assessment
Label & Artwork Compliance Review Report
Product Registration Dossier Outline & Submissions Checklist
Claim Substantiation Summary Package
CONFIDENTIAL ADVISORY
Ready to initiate Regulatory?
Connect directly with our Hyderabad advisory team to map regulatory pathways, audit CMO options, or structure B2B export contracts.
Frequently Asked Questions
We act as strategic regulatory advisors. Submissions are made directly under the client or local sponsor entity, ensuring total IP ownership.
TGA/ARTG (Australia), FSANZ, US FDA, EFSA, HSA (Singapore), NPRA (Malaysia), BPOM (Indonesia), TFDA (Taiwan), FSSAI (India).