Tailored analytical testing protocols designed around your specific peptide, application, and regulatory requirements. From method development to full multi-parameter characterization packages.
Custom analysis at Cert Biohealth Testing Labs includes new method development for non-standard peptides, multi-peptide panel testing at volume pricing, method transfer from internal QC to our lab, tailored reporting formats for regulatory submissions, and bespoke characterization packages for novel therapeutic peptides. We work with research groups, CROs, and pharmaceutical companies to design protocols that fit the work.
Development and ICH Q2(R1) validation of RP-HPLC methods for novel peptide sequences, unusual modifications, or complex formulation matrices.
ESI-MS and LC-MS/MS method optimization for large peptides, cyclic structures, PEGylated conjugates, and multi-component samples.
Bundled testing panels combining purity, identity, endotoxin, heavy metals, and residual solvents into a single submission and single COA document.
COA formats adapted for Health Canada drug submissions (CTAs, ANDAs), USP monograph compliance, or FDA export documentation.
Full characterization packages for peptide reference standards including purity, identity, water content, and counter-ion determination.
Standing agreements for batch-by-batch release testing with guaranteed turnaround windows and preferential pricing for repeat clients.
We discuss your peptide, application, and analytical requirements in a 30-minute call with a senior chemist.
We draft a custom testing protocol and pricing proposal within 2 business days.
We develop and validate the analytical methods against your specific matrix and target specifications.
Samples are processed and analyzed using the agreed protocol with full instrument documentation.
We deliver your report in the agreed format, with all data, spectra, and validation documentation included.
Method development timelines vary based on complexity. For routine peptides with non-standard gradients, expect 5–10 business days. For novel cyclic peptides, lipopeptides, or complex conjugates requiring extensive optimization, allow 3–6 weeks. We provide a timeline estimate before you commit.
Yes. Method transfer is a common service. Please provide your current method (column, mobile phase, gradient, detection wavelength) and a reference standard or in-house characterization data. We will run the transfer, document equivalence, and provide a formal transfer report.
Yes. Clients submitting 5 or more samples per month qualify for preferred pricing and priority turnaround. Monthly standing agreements are available with predictable billing cycles. Contact us to discuss your volume requirements.
Yes. We have experience producing analytical packages for Health Canada Clinical Trial Applications (CTAs) and drug master file submissions. Our reports include all method validation data, instrument qualification records, and analyst certifications required for regulatory review.
Discuss your specific peptide, application, and regulatory needs with our senior analytical team. We build the testing program around you.
+1 (416) 000-0000 | info@certbiohealth.ca