Pharmacovigilance
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Science Division at POLYSAN

Science Division is focusing on all stages of pharmaceutical drug development, studies and post-registration support, it incorporates R&D laboratory, pre-clinical and clinical research department, medical and biological research coordination department and marketing department.

Science Division is aiming to create advanced original pharmaceutical products (from the idea creation up to the production implementation) and to support the product promotion in the practical health care for improving the treatment effectiveness and the quality of life for patients in Russia, CIS countries and South East Asia.

To achieve these goals the Science Division performs the following activities:

Development of pharmaceutical products

POLYSAN has continuously developing R&D Laboratory for creating new products and providing the technical support of manufactured products. It has a wide range of specialists on various forms of drugs (solid, liquid, soft forms), on developing analytical methods, stability study, informational and analytical support.

R&D Laboratory is engaged in the following tasks:

Intellectual Property Protection

Legal protection of original pharmaceutical products is particularly important due to high and increasing costs of creating new drugs and high associated risks. POLYSAN products have no analogs. All compounds, combinations and trademarks are protected by patents, thus assuring the investment protection for new products and technology. The gained profit makes it possible to have continuous R&D financing.

Pharmaceutical product study

Highly qualified specialists on preclinical and clinical trials organize product studies at biggest scientific and medical centers in Russia. The preclinical and clinical trials department is responsible for the full cycle research and all its stages, from working out the study protocol to preparing documents for the registration:

Pharmaceutical product registration

Product registration and re-registration department ensures the timely access to the present pharmaceutical product market. The product registration application is submitted to the corresponding regulatory authority within the country’s healthcare system to receive the approval for the product use in the medical practice. The submitted master file includes the description of the pharmaceutical product manufacture, product quality data and clinical trial results proving the new product safety and efficacy. If the application is approved, the product will come on the market.

Post-registration support for pharmaceutical products

POLYSAN continues the product efficacy study after the market introduction stage as well. Such clinical studies (phase IV trials, or post-marketing studies) are managed by the medical & biological research coordination department. The purpose of such studies is to extend indications for use and to monitor adverse effect frequency according to the pharmacovigilance requirements.

Also this department does consolidation of accumulated scientific data for the marketing department to establish the product promotion policy in the Russian Federation and former CIS countries POLYSAN innovations introduced in the practical healthcare contribute to the faster recovery and improve patients’ quality of life.

All research results are published in top Russian scientific journals, manuals, guidebooks for healthcare professionals.

 
 
Salova str., Bld 72, Unit 2, Litt. A, Saint Petersburg,Russian Federation, 192102 Tel: + 7-812-710-82-25, Fax: +7-812- 764-62-84

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