Our Senior Regulatory Affairs associates are experienced in drug development and validation of regulatory documents, and can advise you through the drug development phase, from the product concept to the issue of the Marketing Authorisation.
 
Our services include e.g.:

• Providing regulatory advisory services
• Assessing the suitability of available documentation, e.g. Chemistry, Manufacturing and Control (CMC) documents,  pre-clinical data, clinical data in terms of quality and compliance with guidelines
• Establishing product development plans for the pharmaceutical development phase, the pre-clinical phase and/or the clinical phase 
• Preparation of pre-submission meetings and scientific advice 
• Product classification

As a Scandinavian CRO ( Contract Research Organisation) we provide local expertise in Norway, Sweden and Denmark,