Our services
Scale up
Scale-up
From the lab bench we can choose the most economically and ecologically viable synthetic process and prepare from grams to some kilos in our kilolab.
Pilot plant
In our pilot plant we can manufacture up to 25-30 kg per batch following the ICH Q7 guidelines if required. We can validate the manufacturing process so you can use the product in clinical trials or as an API.
Research and Development
Initial research and custom synthesis
We can synthesise building blocks, intermediates, APIs or any other molecule you are seeking from milligrams to several grams.
Process development
Synthetic routes can be based on existing literature or we can provide alternative new pathways.
Quality Control and Analysis
Validation of analytical methods
We can validate analytical methods following the ICH-Q2 (R1) guidelines. We can also synthesise impurities and reference standards.
Stability studies
We can perform stability studies following ICH-Q1A (R2) and ICH-Q1B guidelines. We offer both sample storage in climatic chambers and analysis of such samples.
Physical and chemical and microbiological testing
We can do physicochemical and microbiological testing upon request.
Good Manufacturing Practice
Good manufacturing practice
If your target molecule has any regulatory need, we can perform the manufacturing process under cGMP at any scale.
Drug master files
We can write ASMF for existing active substances or new ones for marketing authorisation.
Investigational medicinal product dossier
In addition, IMPDs can be drafted for your molecules to be used in clinical trials.