Radiopharmaceuticals

Drug Substance Dossier (3.2.S)

Complete preparation of Module 3 drug substance sections with radiopharmaceutical-specific adaptations.

• Radionuclide source and decay characterisation (3.2.S.1.3)
• Manufacturing process with nuclear transformation data (3.2.S.2.6)
• Radionuclidic and radiochemical impurity profiling (3.2.S.3.2)
• Radioactivity specification in Becquerel with calibration time zones (3.2.S.4.1)
• Calibration standard justification for reference materials (3.2.S.5)

Drug Product Dossier (3.2.P)

Radiopharmaceutical-specific product documentation with diagnostic vs. therapeutic segregation compliance.

• Radioactive concentration (volumic activity, Bq/mL) declarations (3.2.P.1)
• Radiolabelling procedure suitability and cross-validation (3.2.P.2.3)
• Batch formula with min/max size justification (3.2.P.3.2)
• Acceptance limits: 90–110% diagnostic / 95–105% therapeutic (3.2.P.5.1)
• Pre-release and post-release test plan justification (3.2.P.5.6)

Stability Programme Design (3.2.S.7 / 3.2.P.8)

Customised stability protocols for products with shelf lives under one year and short-lived radionuclides.

• Adapted testing frequency based on shelf-life duration
• Three-batch selection without fixed production scale
• Kit stability with radiolabelling and biodistribution performance data
• In-use shelf life for multi-dose vials (max 8 hours post-reconstitution)
• GCC Guidelines for Stability Testing compliant storage declarations

PET Radiopharmaceutical Submissions

Specialist support for short half-life products that require release prior to completion of all QC tests.

• In-process controls for critical manufacturing parameters (3.2.P.3.4)
• Sterilising filter integrity test protocols (Ph. Eur. 5.1.1)
• Automated synthesis unit description and contamination controls
• Process validation for in-situ radionuclide manufacture (≤20 min half-life)
• Starting material purity controls before batch release

Generator System Documentation

Full generator dossier preparation including elution procedures, eluate specifications, and misuse prevention.

• Mother and daughter radionuclide testing specification
• Eluate specific activity, radionuclidic and chemical impurity tests
• Sterility maintenance during preparation and assembly
• Mother radionuclide breakthrough impurity justification
• Ageing and elution frequency effects on eluate quality

Regulatory Strategy & Gap Analysis

Pre-submission consultation to identify dossier gaps and develop SFDA-compliant regulatory pathways.

• SFDA draft guidance applicability assessment per product type
• GCC data requirements gap analysis and remediation plan
• Ph. Eur. monograph suitability demonstration strategy
• Impurity control strategy for new production routes
• Container closure compatibility and syringe material review

Start Your Radiopharmaceutical Submission

Our regulatory team is experienced with SFDA requirements and GCC data submission frameworks.