About Us
Science-Led Solutions for Drug Innovation
At Pre-therapeutic, we are a team of scientists and CMC professionals with a shared commitment to advancing early-stage drug development through smart, phase-appropriate support. We specialise in diagnostics and therapeutics — particularly radiopharmaceuticals — and provide tailored services across synthesis, analytical development, and full CMC support.
Our expertise covers a wide spectrum, from method development and validation to regulatory documentation, vendor management, and strategic CMC planning. Whether you need support with Module 3 of your IND or IMPD submission, vendor oversight, or radiochemistry method development, we’re here to help.
Our Global Network
While our core team remains lean and focused, we work closely with a trusted network of partners around the world — including CROs, CDMOs, and subject matter experts — enabling us to scale support to meet the specific needs of your project. This agile approach allows us to deliver high-quality, efficient solutions without unnecessary overheads.
Why Work With Us?
- Proven experience in radiopharmaceuticals and CMC
- Flexible, phase-appropriate support
- Access to expert lab-based capabilities
- A global network of trusted development partners
Our Expertise
All work is supported by access to fully equipped laboratory facilities and a trusted network of scientific partners.
Analytical Development
Method design, optimisation, and validation.
Radiochemistry Services
Labelling, formulation, and automation (¹⁸F, ⁶⁸Ga, ¹⁷⁷Lu, and more)
CMC Support
IND/IMPD Module 3 authoring and regulatory preparation.
GMP Sourcing & Oversight
Vendor qualification, audits, and partner management.
What We Offer
We are happy to support almost every aspect of CMC for early-stage development, including but not limited to:
- Synthesis and analytical method development
- Method validation
- CMC authoring for IND/IMPD submissions
- Vendor qualification and management
- GMP material sourcing and oversight
- Regulatory guidance and quality support