Radiopharmaceuticals
Radiopharmaceutical Precursor Development & GMP Manufacture
From route scouting to commercial supply, we develop and manufacture the chelators, linkers and precursor molecules that radiopharmaceuticals are built on, under one integrated, GMP-accredited quality system.
- Overview
- One connected workflow
- Our expertise
- Quality & regulatory infrastructure
- What you can achieve
- Specialist technologies
- FAQs
Radiopharmaceutical precursor programmes usually run across a peptide CRO, a chelator specialist, a separate GMP site and a radiolabelling partner, with a technology transfer and a fresh risk at every step.
We bring precursor route scouting, chelator and linker conjugation, trace-metal-controlled analytics and GMP manufacture together under one quality system, covering the receptor-targeted and next-generation precursor chemistry that sits upstream of radiolabelling, from early candidates through to validated commercial supply.
Quality & Regulatory Infrastructure
GMP-accredited since 2015
ANSM-certified, most recently audited in 2022, with a quality system built on 130+ procedures, 80+ instruction manuals and 300+ forms and templates.
FDA-registered since 2021
Two mock inspections completed to date, with a Pre-Approval Inspection expected in 2026.
Audit-ready, by design
Five DMFs already accepted across the EU, Switzerland and the US, with ten more in preparation, and 10+ client audits hosted every year.
What You Can Achieve
Specialist Technologies
Frequently Asked Questions
Yes. Our site has held ANSM GMP certification since 2015 and has been FDA-registered since 2021, with a Pre-Approval Inspection expected in 2026 and five DMFs already accepted across the EU, Switzerland and the US.
Through ICP-MS analysis built into our development and QC workflows. Metal contaminants such as iron, copper and zinc can compete with the intended radiometal during labelling, so we treat trace-metal control as a core part of precursor characterisation, not an afterthought.