Enterprise Europe Network

Serbian pharmaceutical company offers preclinical development, and testing under subcontracting agreements

Country of origin:
Country: 
SERBIA
Opportunity:
External Id: 
BORS20180305001
Published
18/12/2019
Last update
30/12/2019
Expiration date
30/12/2020

Keywords

Partner keyword: 
Clinical Research, Trials
Pharmaceuticals/fine chemicals
Other human health activities
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Summary

Summary: 
A Serbian company offers subcontracting for the preclinical development (set of toxicology testing, pharmacokinetics, and some of the pharmacodynamics investigations) for human and veterinary medicines and newly synthesised substances according to pharmacopoeial, OECD and GLP standards. The company also offers biocompatibility testing for medical devices, and biological quality control testing of products. The company is looking for collaboration with pharmaceutical companies or laboratories.

Description

Description: 

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.

Advantages & innovations

Cooperation plus value: 
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 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 the CE mark on the products from our dental plant and para-pharmaceutical plant. Likewise, following the 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, complies with Good Manufacturing Practice Guidelines.

Stage of development

Cooperation stage dev stage: 
Already on the market

Partner sought

Cooperation area: 
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 synthesized substances according to pharmacopoeial, OECD and Good Laboratory Practice (GLP) standards. The partner could be both a pharmaceutical company and laboratory. The potential partner could develop its pharmaceutical products or medical devices or provide services to the pharmaceutical industry. The potential partner (company or laboratory) could execute development projects for new medicines or preparations in the preclinical development phase and needs testing for: - acute, subacute and subchronic systemic toxicity, - local tolerance, - test for pyrogens, - abnormal toxicity test. The potential partner could also be a company or laboratory either certifying, testing or developing parts of medical devices in direct contact with biological mater requiring biological testing for quality and biocompatibility control purposes.

Type and size

Cooperation task: 
SME 11-50,SME <10,>500 MNE,251-500,SME 51-250,>500