Preclinical studies

We conduct research and final quality control of the following:

• Originator, hybrid, combined and biosimilar drugs (including therapeutic antibodies)
• Vaccines
• Medical devices
• Medical technologies
• High-tech medicines
• Human cell-based medicinal products

For pharmacodynamics, we have a number of validated models for major pathological processes and diseases such as neurodegenerative diseases, metabolic disorders, cardiovascular diseases, trauma, cancer, and others.

List of preclinical studies:

• General toxic properties (acute, chronic toxicity, local irritant effects)
• Metabolism (toxicokinetics, in vivo pharmacokinetics, in vitro metabolism, drug interactions)
• Specific toxicity (immunogenicity, immunotoxicity, allergenic properties, mutagenicity, carcinogenicity, reproductive toxicity (generative, embryo/fetotoxicity and teratogenic effects)
• Pharmacodynamics (in vitro and in vivo studies, modelling or using transgenic animals and cell lines)
• Comparability of biosimilar drugs
• Cross reactivity of therapeutic antibodies
• Stability
• In vitro biological and immunochemical activity
• Quality control at change of production site
• Quality control of biological drugs
• Final quality control, etc.

We provide preclinical studies on a turnkey basis, encompassing the following services:

• Development and coordination with the customer of the Terms of Reference
• Development of the study plan
• Conducting the experimental part
• Conducting the study on animals
• Preparation of a complete package of documents for the registration dossier