FAQ
Frequently Asked Questions
Everything you need to know about working with Androxa.
What kind of testing does Androxa coordinate?
Androxa coordinates analytical chemistry (HPLC, LC-MS/MS, ICP-MS), microbiology (USP <61>/<62>, BP), stability studies (ICH Q1A/Q1B), impurities profiling, and regulatory consulting. We work across NHPs, pharmaceuticals (Rx and OTC), and cosmetics for the Canadian market.
Are you a single laboratory or a network?
Androxa operates as a multi-laboratory services portal — a Canada-wide network of accredited partner labs. You get a single project manager, one quote, one consolidated report, and access to capabilities across our network.
What credentials do your partner labs hold?
Our partner laboratories hold relevant ISO/IEC 17025 accreditations and operate under pharmaceutical GMP discipline. Specific accreditation scopes depend on the test method assigned. We confirm scope coverage before accepting a project.
Can you support a Health Canada NPN application?
Yes. We provide the analytical data required by the NNHPD for NPN applications — identity, finished product specifications, heavy metals, microbiology, and stability. We can also advise on dossier structure and respond to NNHPD information requests.
What about DIN submissions for drug products?
For DIN-licensed products, we provide CTD Module 3-aligned analytical packages: assay, related substances, dissolution, residual solvents, and stability. Methods are validated to ICH Q2(R1) standards and documented for regulatory review.
How fast is your turnaround?
Standard turnaround depends on the test methodology. Routine microbiology is typically 7–14 days; analytical chemistry 5–10 business days; stability programs follow the protocol timeline. Rush options are available subject to capacity.
Do you support tech transfer between labs?
Yes. Method tech transfer is one of our core consulting capabilities. We coordinate the receiving-lab qualification, comparative testing, and acceptance criteria so you have a documented bridge between sites.
How do you handle confidentiality?
All projects operate under strict confidentiality. Sample formulations, results, and project context are not shared outside the assigned project team. Confidentiality agreements are signed at project inception.
How do I start a project with Androxa?
Submit a quote request through our contact form with your product type, target Canadian regulatory pathway (NPN/DIN/cosmetic), and the testing you need. Our team responds within one business day with method recommendations and a fixed-scope quote.
How does Androxa relate to Qalitex Laboratories?
Androxa is part of the Qalitex Group of laboratory and consulting brands. Qalitex (qalitex.com) is the ISO/IEC 17025 accredited US operations entity in Irvine and San Diego, California. Androxa is the Canadian portal serving Health Canada-regulated products.