Documentation and due-diligence
Documentation that closes the deal.
Documentation packages, COA support, novel food and dietary ingredient submissions support, and counterparty due-diligence packs. Key for your procurement team's approval.
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01 · Documentation pack
The standard deliverables.
Every supply engagement ships with the documentation pack below as standard. Additional dossier components — novel-food, NDI, NHP, AUST L — are scoped against the importer's specific jurisdictional requirements.
- Certificate of Analysis
- Per batch — assay, identity, purity
- Heavy metals
- Pb, As, Cd, Hg per batch
- Pesticide residues
- USP <565> / EU MRL panels
- Microbial
- TPC, Y&M, E. coli, Salmonella
- Material safety
- MSDS, current revision
- Country of origin
- Per consignment, partner-issued
- Method protocol
- Validated HPLC / LC-MS where applicable
- Stability data
- On request, per compound and packaging
02 · Jurisdiction matrix
Submission framework, by market.
Documentation is structured to satisfy the importer's jurisdiction. Where Motark's standard pack is insufficient, the regulatory team works with the client to assemble the required submission package.
Market
United States
Framework
FDA — DSHEA dietary-supplement framework
Notes
NDI notification where applicable; 21 CFR §111 structured packages.
Market
European Union
Framework
EFSA — Regulation (EU) 2015/2283 (Novel Food)
Notes
Per partner-specific submissions; counterparty advised pre-supply.
Market
Australia
Framework
TGA — Listed Medicine framework
Notes
AUST L documentation packages available on request.
Market
Hong Kong
Framework
HKMA · CFS food-grade framework
Notes
Aligned to HKMA counterparty workflow expectations.
Market
ASEAN
Framework
Harmonised ASEAN traditional medicine framework
Notes
Per-jurisdiction documentation; supply contracts adapted to importer's local requirements.
Diligence pack
Request access.
Counterparty due-diligence support, jurisdiction-specific documentation, and compound-level submission packs — assembled per engagement against the importer's regulatory pathway and shared with verified institutional reviewers on request.