We offer coordinated drug development programs providing our pharmaceutical clients an optimized service in terms of speed and cost effectiveness. Testing programs are tailored on the specific requirements of each test drug.
The typical testing program according to ICH Guidelines is usually completed in 6-7 months and include:
- Acute toxicity studies in rodents (2 species 2 administration routes)
- Preliminary range finding studies
- Subacute toxicity studies (rodents and non-rodents)
- Preliminary toxicokinetics
- Genotoxicity studies
- Basic safety Pharmacology tests (CNS, CV and Respiration)
- Bioanalytical development & Validation
- IB (Investigator’s Brochure), IMPD (Investigational Medicinal Product Dossier) upon request