Product and pathway assessment
Confirm the drug, biologic, device, and combination product context; intended clinical use; jurisdiction; and development stage.
Combinate BioWorks
First-in-Human GMP readiness.
Product and stage-specific quality assessments for combination products preparing for clinical use in the United States or European Union.
Define what applies before the first clinical lot.
The assessment connects the product configuration, development stage, clinical pathway, manufacturing model, and constituent-part requirements to a practical GMP readiness plan.
US GMP readiness
Assess stage-appropriate manufacturing and quality controls for IND programs and design-control and manufacturing evidence for IDE programs.
EU GMP readiness
Assess IMP manufacture, testing, release, packaging, labeling, supply-chain controls, and supporting quality documentation for the clinical trial application.
EU device clinical investigation readiness
Assess the quality-system, design, manufacturing, risk, and technical evidence needed to support a clinical investigation application.
External partner readiness
Review CMO, CDMO, laboratory, device supplier, packaging, testing, quality-agreement, and oversight arrangements.
Clinical supply control strategy
Define responsibilities and controls for manufacture, testing, disposition, labeling, storage, shipment, change, deviation, and traceability.
The service supports quality readiness and the development of submission-supporting evidence. Regulatory strategy, submission authorship, clinical operations, Qualified Person certification, and product disposition remain with the responsible sponsor and authorized functions unless separately scoped.