Supporting a Successful Radiopharmaceutical Product Launch

The Challenge

Radiopharmaceutical products present unique regulatory and operational challenges. In this case, the client needed to:

• Establish QP certification and batch release for a time critical product
• Ensure both customs clearance and distribution of the product were completed with minimal time delays
• Demonstrate full oversight and compliance of an international supply chain
• Set up a WDA and associated GDP systems under tight launch timelines
• Ensure regulatory readiness without disrupting ongoing clinical and manufacturing activities

The client required a partner with deep regulatory expertise, practical experience in radiopharmaceuticals, and the ability to integrate and communicate seamlessly with their internal teams.

MIAS Pharma’s Approach

QP Release Services

MIAS Pharma provided experienced QP support, working closely with the client to establish robust batch certification processes aligned with EU GMP requirements. This included review of manufacturing and testing documentation, deviation management, and release decision-making tailored to the product’s short shelf life. The QP framework ensured batches could be released efficiently without compromising compliance or patient safety.

Supply Chain Audits

MIAS Pharma conducted a series of targeted GMP and GDP audits across the client’s supply chain, including manufacturers, contract testing laboratories and logistics providers. Each audit delivered clear, pragmatic findings with risk-based recommendations. Where gaps were identified, MIAS Pharma supported the client in implementing corrective and preventive actions, strengthening overall supply chain governance.

WDA Set-up and GDP Framework

To support commercial distribution, MIAS Pharma led the establishment of a GDP compliant WDA. This included development of GDP procedures leveraging the clients existing quality system. MIAS Pharma also supported the client by providing a local Responsible Person, submitting the WDA application, ensuring inspection readiness and hosting the inspection with the client.

The Outcome

With MIAS Pharma’s support, the client successfully launched their radiopharmaceutical product on schedule. Key outcomes included:

• QP release processes implemented and operating smoothly from day one
• A fully audited, compliant, and inspection-ready supply chain
• A robust WDA and GDP system supporting ongoing commercial distribution
• Increased confidence from regulators, partners, and internal stakeholders

The client continues to work with MIAS Pharma as a trusted partner, leveraging ongoing QP services and quality support as their product portfolio and market presence expand.