Our Services

Core Testing Services

• Impurity Analysis (Phase 1 MVP): Identification and quantification of organic impurities in APIs and drug products using validated compendial methods (USP, BP, EP).
• API, Excipient, and Drug Product Testing: Small molecule pharmaceutical testing under GMP-style protocols.
• Physical Characterization: pH, viscosity, appearance, identity confirmation.
• Compendial Method Execution: USP <467>, <621>, <731>, <851> and related validated methods.

Storage & Stability (Phase 2+)

• GMP Stability Storage: ICH-compliant storage at multiple temperature conditions with timepoint tracking.
• Stability Testing: Full panel release testing at T0, T1, T3, and T6 as per client protocol.
• Temperature-Controlled Storage: Refrigerated and frozen storage for clinical materials, biologics, and samples.

GMP & Regulatory Compliance

All services are aligned with Health Canada and FDA GMP expectations. Our SOPs and lab workflows follow ICH Q7/Q9/Q10, USP/EP specifications, and GLP-compliant documentation standards. We’re building to be audit-ready from day one.

Service Model

• Fee-for-Service: Transparent pricing by test, with itemized cost breakdowns upon request.
• Rapid Turnaround: Expedited timelines available for clients with time-sensitive filings or submissions.
• Client-Centric Approach: We support custom test requests, validation protocols, and regulatory correspondence.
• Data Integrity: All results include CoAs, raw data, and traceability documentation, delivered digitally and/or physically.