Case Studies
Anonymised case studies from our work with Canadian NHP brands, pharmaceutical companies, and CRO/CMO partners.
A multi-SKU botanical brand needed analytical data and dossier formatting to support 12 NPN applications. We coordinated identity, heavy metals, microbiology, and stability across all SKUs in a single program.
Outcome
NPNs granted in the first review cycle for 11 of 12 SKUs.
A pharmaceutical sponsor needed ICH Q2(R1)-validated assay and related-substances methods for a Canadian DIN submission. Tech transfer from US compendial method to a Canadian partner lab.
Outcome
CTD Module 3 package delivered on schedule. Health Canada had no analytical deficiencies.
A CMO needed a turnkey stability program for three new Rx product launches. We designed the protocol, coordinated chamber capacity, and reported pull-point data on the regulatory schedule.
Outcome
Three concurrent stability programs delivered without timeline slippage.
A boutique skincare brand needed PET, microbiology, and ingredient safety data to support Health Canada Cosmetic Notification Forms across 8 SKUs.
Outcome
All 8 SKUs cleared CNF review without Health Canada follow-up.
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Request a Quote →All case studies are anonymised composites. Specific client identities, formulations, and proprietary data are protected by confidentiality agreements.
