Annotation
The Serbian company offers preclinical development (set of toxicology testing, pharmacokinetics, and some of pharmacodynamics investigations) for human and veterinary medicines and newly synthesized substances according to pharmacopoieal, OECD and GLP standards. The company also offers biocompatibility testing for medical devices, and biological quality control testing of pharmaceutical products. The company offers potential partners its services through subcontracting or service agreement.
Offer description
The Serbian company exists over 65 years, and has a track record of scientific research work in development of medicine. The company offers preclinical studies and pharmaceutical development of newly synthesized substances and drugs, and also does biocompatibility testing of medical devices. The company offers acute, subacute and subchronic toxicity tests in accordance with the OECD guidelines. Upon request, the company also provides more types of toxicological tests. All toxicological tests are carried out in accordance with the guidelines of Good Laboratory Practice. 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 in accordance with 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 company offers its services to potential partners in the form of subcontracting or service agreement in field of preclinical development (set of toxicology testing, and pharmacokinetics, as well as some pharmacodynamics investigations) for human and veterinary medicines and newly synthesized substances according 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.
Innovations and advantages
More than 50 years of experience in preclinical investigations and development of drugs. In house production of experimental animals (mice, rats and guinea pigs), and well-trained and experienced staff. The company achieved a numerous awards on national and international exhibitions for its products. The company conducts its studies according to international standards ISO 9001:2008, ISO 13485:2003/MDD 93/42 and HACCP system. The company obtained a certificate for manufacturing and sales of medicinal and dietary products and common use products. They have the right to use CE mark on the products from our dental plant and parapharmaceutical plant. Likewise, in accordance with positive report of the Ministry of Health of the Republic of Serbia, the company. has obtained a GMP certificate, which confirms that the manufacturing of cephalosporin capsules, i.e. medicines for human use, is in compliance with Good Manufacturing Practice Guidelines.
Current stage of development
The company is one of the largest pharmaceutical companies in Serbia.
Technology keywords
06001002 Clinical Research, Trials
Market application codes
05007002 Pharmaceuticals/fine chemicals
Profile date
16.03.2019
Сотрудничество
Area of partner's activity
The company seeks partner which needs preclinical development (set of toxicology testing, and pharmacokinetics, as well as some pharmacodynamics investigations) for human and veterinary medicines and newly syntetized substances according pharmacopoieal, OECD and GLP standards.
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