Supplier qualification and risk-based assessment
Start from intended use and criticality, then establish proportionate qualification and appropriate supplier controls.
Expertise
Suppliers do not need to make radiopharmaceuticals to impact your operation.
Supplier Assurance for Radiopharmaceutical Operations. We connect supplier capabilities with the impact of their products and services on the customer's GMP compliance, product quality and operational reliability.
Where we add value
Bring us in where disciplines begin to depend on each other.
A supplier may work outside the radiopharmaceutical industry and still affect process validation, product quality, documentation or time-critical manufacturing. We evaluate its capabilities in the context of your actual process, not merely its industry label.
Connected expertise
We help connect those two realities.
Supplier audits and technical evaluation
Evaluate relevant quality capabilities, technical suitability and interfaces, with practical follow-up of findings.
Quality agreements and responsibilities
Clarify specifications, quality expectations, supplier changes, communication and escalation responsibilities.
Change and supply-chain risk oversight
Understand how changes at suppliers can affect validation, GMP controls, operational reliability and continuity of supply.
Periodic supplier evaluation
Review supplier performance and emerging risks using a proportionate, maintainable oversight process.
Supplier assurance programme design
Establish risk-based qualification, monitoring and oversight processes that the customer can operate and own.
Why this works
Proportionate assurance, not unnecessary bureaucracy.
Not every supplier requires the same qualification depth or GMP controls. We assess the impact on the customer's radiopharmaceutical process and choose controls that address the real risks, without imposing unrelated pharmaceutical requirements.
Start with the problem