GMP Drug Substance
Integrated GMP Transition – Smooth, Compliant, and Completely Managed By Us
We take your molecule from development to GMP manufacture through a fully integrated model. You work with one team — CatSci — while we coordinate every technical, analytical, and operational detail with our trusted GMP partners.
- Overview
- How we deliver a seamless GMP transition
- What you can achieve
- Explore related services
- Benefits to your programme
- Our trusted partners
- In our own words
- FAQs
The Importance of GMP Substance Manufacture
Transitioning into GMP manufacture is a critical milestone. It’s one that depends on robust process design, validated analytics, and precise documentation. Gaps or inconsistencies at this stage can lead to costly delays or regulatory setbacks.
At CatSci, we prepare your process for success before it ever enters the plant and manage the journey so you don’t have to. Our experts deliver phase-appropriate CMC data, validated analytical methods, and complete technology transfer packages. We then work directly with our trusted GMP partners, including AGC Pharma Chemicals Europe, to oversee the scale-up, technology transfer, and manufacturing integration.
You remain in partnership with one accountable team — CatSci — while we handle every detail behind the scenes, ensuring your process performs exactly as designed, under GMP conditions.
What You Can Achieve
Our Trusted Partners
Your GMP manufacturing journey benefits from CatSci’s network of carefully selected and audited partners. Our long-standing relationships means you have peace-of-mind in your move into GMP, offering global capability with CatSci as your single point of contact.
We collaborate with leading CDMOs and manufacturing sites, all aligned to CatSci’s stringent standards of quality, safety, and transparency.
Together, we provide an integrated solution that feels in-house: seamless tech transfer, continuous oversight, and a unified scientific vision from development to GMP production.
Frequently Asked Questions
GMP drug substance manufacturing is the controlled, compliant production of the active ingredient in a medicine under regulatory standards. It ensures every batch meets strict quality, safety, and data integrity requirements for use in clinical and commercial products. CatSci delivers full GMP readiness through validated processes and managed tech transfer to trusted GMP partners.
CatSci manages every step of the transition from process development to GMP manufacturing. We ensure routes, control strategies, and analytical methods are validated, then coordinate directly with our GMP partners to transfer the process seamlessly, whilst maintaining full scientific oversight and traceability throughout.
CatSci collaborates with a network of trusted GMP CDMOs, including AGC Pharma Chemicals Europe. All partners are audited and aligned with CatSci’s standards for quality, transparency, and regulatory compliance, ensuring a unified, end-to-end GMP solution.
CatSci’s single-partner model eliminates hand-off risks and accelerates progression. You work with one accountable team that manages process readiness, analytical validation, and GMP coordination. We ensure control, continuity, and compliance from bench to plant.