Advanced Analytical Testing Laboratory
Globyz Clinical Solutions provides regulatory focused chemical testing and advanced instrumental analysis for pharmaceutical and health product organizations. Testing is performed within the laboratory's current authorized scope for chemical testing using controlled procedures, qualified equipment, approved or accepted methods, trained personnel, and documented data integrity controls. The analytical platform includes advanced instrumentation and supporting laboratory systems for a broad range of chemical and instrumental testing, subject to method suitability and project-specific technical, quality and readiness review. Microbiology services are coordinated through a qualified partner laboratory based on project requirements.
Testing Accepted Through Technical Review
Every enquiry is reviewed for method suitability, specification alignment, product matrix, sample quantity, reference standards, columns and consumables, equipment configuration, qualification status, personnel readiness, storage requirements, reporting expectations, and target date. Acceptance and timing are confirmed only after technical and quality review.
Analytical Laboratory Services
Pharmaceutical Analytical Testing
Chemical testing for accepted pharmaceutical materials and products within the current authorized and qualified scope.
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Method Transfer and Verification
Documented review, transfer, or verification of compendial and client methods before routine use.
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Method Development & Validation Support
Fit for purpose method work, validation planning, execution, and lifecycle support when technically feasible and approved.
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Chromatography & Mass Spectrometry
Advanced analytical testing for accepted assays, impurity evaluation, quantitative analyses and method-specific applications.
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Elemental Impurity Testing
ICP-MS based elemental analysis for accepted materials and products using a suitable method and approved test panel.
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Spectroscopy and Identification
UV-Vis and FTIR applications for accepted identification, quantitative, and material characterization requirements.
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Raw Materials, APIs & Excipients
Identity, assay, impurity, water content, physicochemical, and other approved testing against accepted specifications.
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Finished Products & Batch Testing
Chemical quality testing and controlled reporting using approved specifications and suitable methods.
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Dissolution and Product Performance
Dissolution, disintegration, and related product performance testing where methods and equipment are suitable and qualified.
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Laboratory Quality & Regulatory Framework
Controlled methods, equipment, records, data review, investigations, reporting, archival, and client oversight.
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Sample Submission
Required information, documentation, quantities, standards, shipping, storage, and chain of custody instructions.
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Partner Coordinated Microbiology
Microbiology testing coordinated through a qualified partner laboratory with disclosed responsibilities and quality oversight.
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Depending on the product, specification, method, and current qualified capability, testing may include identification, assay, related substances or specified impurities, dissolution, disintegration, water content, pH, elemental impurities, spectroscopic identification, chromatographic analysis, mass spectrometric analysis, and selected physical or chemical quality tests. Each test is accepted only after confirmation of authorization, method suitability, equipment readiness, trained personnel, materials, sample requirements, and quality expectations.
Products and Matrices
The current focus includes pharmaceutical raw materials, active pharmaceutical ingredients, excipients, solid oral dosage forms, finished products, and selected non sterile products accepted after technical review. Globyz Clinical Solutions provides chemical testing for natural health products, cosmetics and other health product matrices following confirmation of the applicable method, specification, sample and regulatory requirements.
Methods and Standards
Testing may use applicable compendial procedures, approved client methods, transferred methods, or validated laboratory methods. Before routine use, each method is reviewed for intended use, specification alignment, product matrix, system suitability, standards, equipment, software, calculations, verification or validation requirements, and reporting expectations. Applicable references may include USP and NF, Ph. Eur. or BP, and other recognized standards relevant to the product and target market.
Analytical Platform and Technical Capability
Globyz Clinical Solutions maintains qualified analytical instrumentation and supporting laboratory systems for a broad range of chemical and instrumental testing. The analytical platform supports identification, assay, impurity evaluation, dissolution sample analysis, stability testing, quantitative and trace-level analysis, elemental analysis, material characterization and other method-specific applications.
All systems assigned to testing are appropriately installed, qualified, calibrated, maintained and operated by trained personnel. Testing is undertaken following confirmation of method suitability, technical readiness, required standards and controls, and applicable quality requirements.
Microbiology Through a Qualified Partner Laboratory
Microbiology services are delivered in coordination with our qualified partner laboratory in accordance with approved specifications and agreed project requirements. Globyz Clinical Solutions coordinates the assignment and maintains oversight of method responsibilities, sample flow, quality activities, data review, reporting and investigations within the defined scope.
From Enquiry to Report
Submit
Provide the product, specification, method, sample details, test list, target date, and reporting needs.
Review
The laboratory evaluates feasibility, gaps, equipment, standards, materials, sample quantities, responsibilities, and timing.
Quote and Agree
Scope, method work, samples, materials, pass through costs, reporting, and quality terms are confirmed.
Execute
Testing is scheduled and performed under controlled procedures with documented review and issue management.
Report
The agreed certificate, analytical report, transfer report, validation report, or investigation report is reviewed and issued.
Submit
Provide the product, specification, method, sample details, test list, target date, and reporting needs.
Review
The laboratory evaluates feasibility, gaps, equipment, standards, materials, sample quantities, responsibilities, and timing.
Quote and Agree
Scope, method work, samples, materials, pass through costs, reporting, and quality terms are confirmed.
Execute
Testing is scheduled and performed under controlled procedures with documented review and issue management.
Report
The agreed certificate, analytical report, transfer report, validation report, or investigation report is reviewed and issued.
Start an Analytical
Discussion.
Reach out to our experts for a technical review of your analytical requirements and tailored quote.