… an internationally active research institute working for the chemical and pharmaceutical industries.
Working on the basis of customer specifications, we develop pharmaceutical raw materials, modern drug dosage forms and finished drug products from lab-scale trials right through to industrial production. Each stage of research is supported by in-house chemical, physical and microbiological analyses. The analytical procedures and techniques employed are fully compliant with the current specifications in the pharmacopoeias. If necessary, we will also develop and validate analytical methods and procedures.
With many years experience in compiling medical, pharmacological and pharmaceutical reports, we are well qualified to prepare the requisite documentation for active substance master files (ASM), certificates of suitability of the monographs of the European pharmakopöe (CEP) and EC-GMP qualification.
Our Regulatory Affairs Department draws up national and international drug approval applications (Mutual Recognition Procedure). Existing dossiers are updated and systematically archived in accordance with the relevant guidelines.
Projects are coordinated closely with our customers and are executed by interdisciplinary teams whose members are drawn from a range of specialist departments. Regular meetings to discuss progress and recent developments guarantee the success of the project.
If you would like to know more, simply contact us to discuss your project requirements.
Working to keep you healthy.