The Serbian company exists over 65 years and has a track record of scientific research work in the development of medicine. The company offers preclinical studies and pharmaceutical development of newly synthesised substances and drugs, and also does biocompatibility testing of medical devices. The company offers acute, subacute and subchronic toxicity tests following the OECD guidelines. Upon request, the company also provides more types of toxicological tests. All toxicological tests are carried out following the guidelines of Good Laboratory Practice (GLP).
The company performs pharmacokinetic studies in model rats and rabbits, e.g., pharmacodynamic tests of drugs and dietetic supplements. They have experience in the production of animal models (obesity, stress, osteoporosis, cancer, etc.). They conduct biocompatibility tests of medical devices following the ISO 10993 standard. The company conducts its studies according to international standards ISO 9001:2008, ISO 13485:2003/MDD 93/42 and HACCP system.
The tests performed at the company include non-clinical trials of medicines, biologically active substances and biocompatibility testing of medical devices for new product development, quality control and marketing authorisation of products.
Toxicology tests performed by the company are:
- Acute, subacute and subchronic systemic toxicity;
- Local tolerance (intramuscular, oral, dermal, vaginal, rectal, ocular, nasal and gingival) ;
- Test for pyrogens;
- Abnormal toxicity test.
Medical device biocompatibility testing offered as subcontracting service by the company are :
- Primary and cumulative skin irritation tests;
- Sensitisation tests;
- Test for local effects following implantation;
- Medical device systemic toxicity testing (acute, subacute, subchronic).
For testing efficacy of substances, several animal models have been developed and verified by the company, such as hyperlipidaemia and obesity in rats, subcutaneous mice melanoma, multiple sclerosis models and rat osteoporosis model.
The company offers its services to potential partners in the form of subcontracting in the field of preclinical development (set of toxicology testing, and pharmacokinetics, as well as some pharmacodynamics investigations) for human and veterinary medicines and newly synthesised substances according to pharmacopoeia, OECD and GLP standards. The company also offers services of biocompatibility testing for medical devices, and biological testing for quality control purposes of finished pharmaceutical products. The potential partner could be a pharmaceutical company or laboratory providing services to the pharmaceutical industry needing to benchmark its procedures.