Strategic partnership, development and manufacturing for the pharmaceutical industry

Whether you need to develop a synthesis method or already have one available: We are your ideal partner when it comes to pharmaceutical excipients, intermediates or APIs for toxicology or clinical development. With our scale-up options and tech transfer in our cGMP multi-purpose facility, we are able to provide flexible quantities by the ton.

We bundle knowledge: For every project, we form a special project team made up of the right experts for the respective requirement profile. Our experienced synthesis and industrial chemists, analysts, safety and environmental experts and quality control staff work together to develop an optimal, tailor-made solution for every customer. As a medium-sized company, we have short communication paths: Depending on your needs, either the manager of the project group or functional specialists are available as direct contacts throughout the project. 

Controlled quality: We manufacture in accordance with the guidelines of Good Manufacturing Practice (GMP) for pharmaceutical ingredients (APIs) (Art. 111 (5) of directive 2001/83/EC). Our manufacturing facility is regularly inspected by the US FDA and EU health authorities. More information about our professional quality management is available here.

• Synthesis research and process development including provision of lab samples up to multiple 100 grams
• Analytical methods development and validation in accordance with current ICH guidelines
• Reference standard qualification
• Impurity synthesis
• Stability studies according to current ICH guidelines
• Scale-up and provision of material for clinical phases I to III
• Tech transfer, process validation and provision of commercial quantities by the ton
• Regulatory support
• Continuous process improvement on the basis of observation, documentation and evaluation of quality-related parameters
• Secured supply chain through implementation of business continuity procedures, like qualification of secondary suppliers for key raw materials or establishment of an alternative production site within our company group network.