We provide consultancy on pharmaceutical development strategies, preclinical and clinical testing of pharmaceuticals, interpretation of experimental studies, and safety assessment of products. We know the legislative requirements for registration of a new pharmaceutical and have comprehensive experience in management of pharmaco-toxicological programmes in the entire development of pharmaceuticals.
We specialise in conducting environmental risk assessments of pharmaceutical products according to EMEA guidelines. To support these studies we have a fully equipped ecotoxicological laboratory that performs GLP tests in accordance with ISO 17025 and is accredited by DANAK (the Danish Accreditation and Metrology Fund). According to the ICH guidelines, pilot production and full-scale production of biotechnology-derived medicinal products must meet with specific quality criteria.
Services:
- Toxicological risk assessment incl. QSAR
- Environmental risk assessment
- Scientific and legislative advise
- Strategic consultancy incl. project management using lean principles
- Initial data screening and in-depth data search
- Selection of contract laboratories, invitation of contract offers and management of studies
- Preparation of project specific documents, i.e. protocols, reports, eCTDs and scientific papers
- Assessment of possible residues and impurities according to ICH guidelines, including “leachables”
- Quality assessment of cell substrates for biotechnology-derived medicinal products
- Support and revision of quality documentation
- Life Cycle Assessment (Green Accounts)