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Natural Health Product Submissions

Get your NHP to market—fast, compliant, and claim-credible. OakLS plans, authors, and steers Product Licence Applications (PLAs) and Site Licences (SLs) with proportionate evidence and clean interfaces with Health Canada’s NNHPD.

Why Oak LS?

  • Monograph mastery: Efficient Class I (compendial) attestations when possible; smart upgrades to Class II/III when claims or formats need it. 
  • Proportionate evidence: Modern and traditional evidence strategies that right-size studies to support stronger, compliant claims. 
  • End-to-end execution: From formula and label to NPN issuance—and post-licence changes. 

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What We Do

Feasibility, Classification & Claim Strategy

  • Product fit: NHP vs DIN/device/food; red-flag ingredient/schedule checks. 
  • Claim laddering (e.g., “helps to,” structure/function) mapped to minimum adequate evidence. 
  • Monograph leverage vs. custom evidence; homeopathic/exclusions triage if applicable. 

Evidence & Dossier Build

  • Literature packages (modern/traditional), quality of evidence grading, and gap closure plans. 
  • Proportionate protocols (when needed) to enhance claim strength without “drug-sized” trials. 
  • Quality (GMP) package: specs, stability, CoAs, manufacturing flow; NHP Master File referencing when available. 

Label & Packaging

  • Bilingual (EN/FR) labels aligned to monographs or custom claims; compliant risk statements and non-medicinal lists. 
  • Format checks (dosage form, sub-population, dose ranges) to preserve monograph eligibility. 

Submissions & Interface

  • PLA authoring: Class I/II/III with rationale, evidence summary, and quality sections. 
  • Responses: Clarimails/IRNs, deficiency letters; amendment or negotiation of claim wording. 
  • Site Licence (SL): manufacturer/packer/labeller/importer applications and renewals; SOP/GMP gap-close. 

Post-Licensing Support

  • NPN maintenance & changes: Notifications vs. amendments; formula, label, and manufacturing updates. 
  • PV for NHPs: AE capture and serious AE reporting; signal tracking proportionate to risk. 
  • Advertising and promotion review for compliant copy. 

Typical Pathways We Run

  • Class I (compendial/monograph attestation): fastest route to NPN 
  • Class II (non-compendial evidence leveraging monographs): for modest claim/format deviations 
  • Class III (full review): for novel combos, formats, or stronger claims 


Outcome: a defensible NPN with labels that sell—and a clean path to maintain and enhance claims over time. 

Deliverables

Optional Add-Ons

Optional Add-Ons

  • Regulatory Strategy Brief (classification, claim map, Class I/II/III route, timeline) 
  • Evidence Package (literature tables, weighting, summaries)
  • Label Set (outer/inner, bilingual) 
  • PLA dossier (ready for e-submission) + response kits 
  • Site Licence file (forms, SOP index, GMP evidence) 
  • Post-licence change plan & PV checklist 

Optional Add-Ons

Optional Add-Ons

Optional Add-Ons

  • Proportionate clinical protocol & report to upgrade claims 
  • Name safety (LASA) screening and brand guidance 
  • Retail/market readiness: facts panels, display copy, claims substantiation binder 

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