CDMO Development and Manufacturing Services.
Supporting from you pre-clinical to market.
Expertise
Our Leadership team has extensive collective experience in steering products from pre-clinical to commercial manufacture.
Science-led
Our approach is scientific, collaborative and open, ensuring an open dialogue and transparency that fits your project.
Award-winning
We are a leading CDMO recognised for numerous awards including a King's Award For Enterprise.
Nimble
We adapt to your project needs, and pledge to never relegating it to the bottom of the list.
Expertise you can trust.
We specialise in advancing your molecule from early feasibility to final dosage form, ready for clinical testing and manufacture.
With over 25 years of experience, our science-led formulation development is backed by a team of industry experts. From formulation development to GMP manufacturing, QC and comprehensive analytical capabilities, we know what it takes to provide seamless integrated support, ensuring a smooth transition from lab to clinic.
Formulation
Development
Our team has extensive experience in selecting the correct oral, nasal and pulmonary dosage forms to ensure success in getting to the clinic.
- Formulation and analytical development
- Toxicology supplies
- ASAP stability to support clinical prototype selection
Phase 1 - Phase 2 Clinical Supply
We can help you accelerate to Phase 1 clinical trials through formulation optimisation and identify the next steps to transition into Phase 2 clinical trials following Phase 1 data.
- Clinical manufacturing and QC testing
- Qualified Person Release
- Clinical stability
Process Scale-Up for Phase 3
We understand the complexities of scale up and technical transfer. Covering all aspects from equipment consideration through to manufacturing handover and QC. to dfdfdgdfgfdgfd
- Process optimisation robustness (Qbd, DoE)
- Method validation
- Cleaning validation
Registration
Batches
We support your product’s journey to market with comprehensive registration activities, including preparing and submitting NDA/BLA regulatory filings to streamline your approval process.
- NDA/BLA submission
- Batch manufacture and stability
- Analytical support (dissolution development / risk assessments)
Analytical Development and Validation
Our dedicated QC and analytical teams provide phase appropriate validation of your analytical methods and performance of QC and release testing including:
- Assay, Content uniformity and related substances by HPLC
- Performance testing including Dissolution and Disintegration
- IC Stability testing
Regulatory Affairs Support
Dedicated regulatory resources to protect your confidentiality that spans the following phases of your products development pathway.
- Clinical trials
- Regulatory strategy
- Gap analysis
- Classifications
- Marketing applications
By Development Stage
Pre-clinical
(Pre-clinical - Phase 1)
Supporting you with formulation development to accelerate to the clinic.
Early Phase
(Phase 1 - Phase 2)
Helping you transition from Phase 1 to Phase 2 with confidence.
Late Phase
(Phase 3 - Commercial)
Progress through late-stage with scale-up and commercial expertise.
