Delivering High-Value Pharmaceutical Innovation
Technology-driven pharmaceutical R&D company founded in 2002. We develop high-value therapeutics, APIs, and new chemical entities within GMP-certified environments for clinical and pharmaceutical use. We also provide trusted CRO services for third-party research and development.
Our Services
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.
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.
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.
Our products
Fine
chemicals
High-purity chemical compounds developed for pharmaceutical and research applications.
Impurities
of pharmaceuticals
Reference impurities and analytical materials produced for pharmaceutical testing and validation.
Chemical intermediates
Specialized chemical intermediates designed to support complex synthesis and manufacturing processes.
New
molecules
Research and development of innovative molecules with therapeutic potential and commercial value.
Small
volume APIs
GMP-compliant active pharmaceutical ingredients produced in small-scale batches for clinical and specialized use.
Small
volume drugs
GMP-compliant active pharmaceutical ingredients produced in small-scale batches for clinical and specialized use.
Our Equipment
& Facilities
Medalchemy offers a wide range of laboratory and pilot plant facilities for chemical and pharmaceutical projects. We also have access to specialist equipment for the distillation of kilo quantities of high-boiling, heat-sensitive materials, as well as low-temperature reactions down to -90°C. Projects can be carried out under cGMP or ISO 9000 environments upon request.
Available equipment
- Glass-lined jacketed reactors
- Stainless steel jacketed reactors
- Borosilicate jacketed reactors
- High-vacuum short-path distillation unit
- Stainless steel centrifuges (vertical type)
- Nutsche filters
- Vacuum tray dryers
- Vacuum rotary dryer
- Mill
- Tumble sieve