Regulatory & evidence
Regulatory applications and evidence-building from functional claims to additives and labeling.
Major regulatory filings we handle
Foods with Function Claims
Systematic reviews or human trials on the final product. End-to-end support from active ingredient, mechanism and safety to label drafting.
GRAS / NDI
Requirement analysis, dossier drafting and FDA liaison for GRAS (self-affirmed / notification) and NDI (New Dietary Ingredient).
Novel Food / Health Claim
EU Novel Food applications and Health Claims (Art. 13.5 / 14). EFSA correspondence and evidence design.
Australia / NZ Novel Food
FSANZ Novel Food assessments and High Level Health Claim filings.
New Food Ingredients / Blue Hat
New food ingredient applications (NHC) and Health Food (Blue Hat) registrations/filings (SAMR).
Korea MFDS filings
Individually recognised Health Functional Food applications and clinical protocol design.
Joint support with ORTHOMEDICO
WORSO scope
- Country-level regulatory analysis and strategy design
- Filing-route selection (notification / registration / prior evaluation)
- Local authority liaison, agent and language coordination
- Label drafts and packaging development
- Post-filing customs and distribution coordination
ORTHOMEDICO scope
- Human trial protocol design and execution
- Systematic reviews
- Safety and efficacy literature surveys
- Statistical analysis and publication
- Full-service CRO operations
Process steps
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1
Requirement analysis
Review target-country schemes and required evidence; assess feasibility.
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2
Evidence strategy
Decide whether existing literature suffices or new human trials are needed; optimise cost-effectiveness.
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3
Trials and research
ORTHOMEDICO leads the human trials and systematic reviews.
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4
Dossier drafting
Prepare country-specific application forms and supporting documents.
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5
Authority response
End-to-end support for Q&A, supplementary submissions and local agent coordination.
Turn evidence into pricing power
Bridge clinical evidence to regulation, labelling, filings and distribution — and maximise product value.
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