GMP consultancy for nuclear medicine
Regulatory expertise to help radiopharmacies and nuclear medicine departments achieve and maintain GMP compliance across EU and Mexican regulations.
GMP Gap Analysis
Comprehensive assessment of your current practices against EU GMP Annex 1 & 3 and COFEPRIS requirements.
SOP Development
Writing and review of Standard Operating Procedures for radiopharmacy operations, QC, and equipment qualification.
Facility Design Review
Consultancy on cleanroom design, airflow, contamination control, and containment for new or renovated radiopharmacies.
Audit Preparation
Pre-inspection preparation and mock audits to ensure readiness for regulatory inspections.
Regulatory Affairs
Support for MA applications, variations, and license renewals in Belgium, EU, and Mexico.
Qualification & Validation
IQ/OQ/PQ protocols for equipment, cleanrooms, and computerised systems in nuclear medicine environments.