Real results from real brands

The Challenge

A mid-size dietary supplement brand with 12 SKUs was expanding into retail and Amazon FBA. They had been using a non-accredited lab and received pushback from multiple retailers requesting ISO 17025 Certificates of Analysis. Their existing CoAs were incomplete — missing method references, analyst signatures, and some required tests.

Our Approach

Qalitex ran a full compliance panel on all 12 SKUs covering potency (HPLC), microbiology (USP <61>/<62>), heavy metals (ICP-MS), and identity testing. We also reviewed their existing label claims against actual assay results to flag two products where potency was below label claim.

Results

• ✓ All 12 SKUs tested and CoAs delivered within 21 days
• ✓ Two products flagged for potency below label claim — reformulated and retested
• ✓ ISO 17025 CoAs accepted by all target retailers on first submission
• ✓ Brand onboarded to Amazon FBA within 45 days of engagement

Services Used

The Challenge

A DTC skincare brand experienced two product recalls in 6 months due to microbial contamination in their facial serum line. Their preservative system was under-performing, but they had no data to prove it. EU importers were threatening to drop the brand over safety concerns.

Our Approach

Qalitex performed preservative efficacy testing (PET) per USP <51> and ISO 11930 on all five serum formulations. We also ran an accelerated stability study (40°C/75% RH) over 3 months to evaluate shelf-life under stress. Two formulations failed PET within 14 days.

Results

• ✓ Root cause identified: insufficient preservative in 2 of 5 formulations
• ✓ Reformulated products passed PET within 4 weeks of re-submission
• ✓ No product recalls in 12 months post-engagement
• ✓ EU importers renewed contracts based on validated stability data

Services Used

The Challenge

A top-selling Amazon supplement brand had their flagship protein powder listing suspended after a customer complaint triggered a safety review. Amazon demanded third-party testing from an ISO 17025 accredited lab within 7 days or the listing would be permanently removed. The brand had no existing lab relationship.

Our Approach

Qalitex expedited a full Amazon compliance panel: heavy metals (ICP-MS for As/Cd/Pb/Hg), microbiology (TAMC/TYMC + pathogens), identity verification, and potency assay. We provided Amazon-formatted CoAs with all required fields, method references, and accreditation details.

Results

• ✓ All testing completed in 3 business days from sample receipt
• ✓ Amazon-formatted CoAs submitted on day 4
• ✓ Listing reinstated on day 5 — no revenue loss beyond suspension period
• ✓ Brand enrolled in ongoing monthly testing program to prevent future issues

Services Used