With you frompre-clinicalto market.
Pharmaceutical development and manufacturing CDMO services.
About Us
CDMO services.
Simply, delivered better.
As a leading Contract, Development and Manufacturing Organisation (CDMO) our defining traits lie in our adaptability and nimbleness, enabling rapid product introduction.
Through a science-led approach we align to your drug development needs from pre-clinical to late phase commercial manufacture.
With more than 25 years of experience, count on us to navigate the complexities of your project with precision, expertise and our unique approach to project delivery.
Our CDMO Services
Science-led delivery
Expertise you can trust.
Our team support you at each stage from pre-clinical to market, with phase-appropriate solutions and expertise.
- Formulation development
- Phase 1 to Phase 3 clinical supply
- Process scale-up and optimisation
- Registration activities
- Analytical development and validation
Pre-Clinical Development
Formulation development, prototype screening and stability, method development and qualification.
Phase 1 -2 Clinical Supply
Phase 1 – 2 clinical manufacturing, QC testing, ICH stability, Qualified Person Release, Clinical Stability.
Process Scale-Up for Phase 3
Process robustness (DoE), method validation, cleaning validation, ICH stability, QP release.
Registration
Scale-up and batch manufacture, NDA/BLA submission, process QbD, full stability studies, risk assessements.
Process Validation & Launch
Manufacture of launch supplies, stability studies, NDA QC dissolution method and CR dissolution.
Regulatory Support
CMC strategy, gap analysis and classifications, regulatory agency support, marketing applications.
Our Project Delivery
Experts across all layers of our business.
Our project teams are made up of subject experts from across our business. With oversight from an Executive Leadership Team member on every project, our approach ensures we can make decisions quickly, collaborate, and leverage expertise across our business to navigate complexities and ensure your project’s success.
Our Mission
We are dedicated to changing the lives of patients.
Passionate about science, we strive to build strong customer relationships and exceed their expectations.
We develop and manufacture high-quality drug products and share in our customers’ dedication to change the lives of patients.
Our Development and Manufacturing Facilities
We are flexible and nimble.
Our extensive expertise encompasses the development, scale-up, manufacturing, and rigorous testing of oral, pulmonary, and nasal drug products.
Our flexibility ensures that we can problem-solve, meet your timescales, and deliver solutions that meet patient targets.