Linz, Austria Site

Specialized Capabilities

Small molecule and polymer API production for clinical and commercial materials (cGMP, Halal, Kosher)

Production scales ranging from 100 kg to hundreds of metric tons
Optimization and upscaling of chemical processes, QbDapproach (Quality by Design)

Process development from early clinical phase up to commercial production

Analytical method development and phase appropriate method validations Proven Acceptable Range (PAR), process safety studies, stability studies and solid state investigations

Micro reactors/flow chemistry for developmental quantities and commercial productions

Process transfers

Raw material sourcing and outsourcing, external manufacturing

Registration, validation, product launch

Support customer’s filing activities (CMC, DMF) -FDA, EMA, PMDA, etc.

Regulatory support (audits of any regulatory authorities, registration/validation, ICH stability studies, support and consultancy in filing strategy, filing of regulatory documents for submission [NDA/CMC, DMF])

This site features a strong regulatory inspection history from all major international regulatory agencies, including an FDA inspection in June 2017 with no 483s.

Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.

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