A drug development consulting service
Toxicology and Medical Writing
- Nonclinical overviews and preclinical parts of IB, IMPD, IND, etc.
- Biocompatibility Assessments for Medical Devices (acc. to DIN EN ISO 10993)
- Toxicological Risk Assessments for Impurities, Leachables & Extractables
- Determination of Permitted Daily Exposure and Occupational Exposure Limits
- Environmental Risk Assessments
- Toxicologic pathology for GLP studies
- Pathology peer reviews
- Discovery pathology and characterization of disease models
- Phenotyping of genetically-modified mice
- Diagnostic pathology for laboratory animals
- Pathology expert statements
Project and Portfolio management
- Project evaluations and due diligence support
- Innovation management
- Project Management
- Preclinical development plans and budgets
- Study outsourcing and monitoring
- GLP audits
an established provider of preclinical consultancy services. Our portfolio of services covers all aspects of the preclinical phase of drug and medical device development, from the scientific evaluation and selection of candidate compounds, through the planning and execution of entire preclinical development programs, to the support of regulatory interactions. Our primary focus is a partnership with our clients and the delivery of highest scientific quality, without ever losing sight of the big picture and economic conditions.
Eliminate insurmountable hurdles and unratable risks with our expert support, the path through preclinical development.
are academic labs, start-ups, small- and mid-size pharmaceutical and biotechnology companies, venture capital organizations and investors who seek expert advice in the early development of drugs and medical devices. These clients benefit from our experience that we gained from supporting hundreds of different molecules in preclinical development. Our experience includes food additives, small molecules and biotechnology-derived drugs, vaccines, medical devices and drug-device combinations, all developed in a broad range of clinical indications.