In addition to pharmaceuticals, SAXOCON’s team of Toxicologists are experienced with the evaluation of combination products and medical devices. We have worked with a diverse range of drug delivery systems and drug impregnated devices across the pharmaceutical and medical device industry. This has encompassed a varying spectrum of administration routes and methods of product application. Through our experiences we have developed knowledge of satisfying the expectations and requisites of European health authorities, in addition to those of the U.S. FDA. SAXOCON are able to provide toxicological risk assessments of combination products to demonstrate overall safety and support regulatory submissions.
- In-Silico Screening of Drug Candidates in Early and Late Phase Development
- Qualification of Impurities in Drug Substances and Drug Products (ICH Q3A-Q3D)
- Hazards Assessments and Compound-Specific Risk Assessments for Genotoxic Impurities (ICH M7)
- Risk Assessment of Extractables and Leachables
- Toxicological Profiling and Safety Evaluation of Excipients
- Safety Evaluation of Combination Products and Medical Devices
- What is (Q)SAR