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pharmacovigilance

IRWIN 2 OOO

Medicines registration and development centre

ABOUT THE LABORATORY

Medicines Development and Registration Center

The IRWIN 2 OOO (MDRC) medicines development and registration center develops drugs under the Pharma 2020 import substitution program in order to increase the production of socially important domestic drugs and ensure access of the public to quality and safe medicines

Key areas of activity:

development of the formulation and technology of production of solid dosage forms

development and validation of control methods applicable to finished dosage forms

stability studies of developed dosage forms

drug efficacy and safety studies (pre-clinical and clinical studies) at major Russian scientific centers

full medicine registration cycle in the Russian Federation and transfer of technologies and control methods to the manufacturing site

standardization of requirements for the quality of drugs according to international requirements and the regulatory requirements of the Russian Federation

EQUIPMENT

The MDRC is fitted out with modern laboratory equipment

Chromatographs, Waters and Shimadzu

Climatic chambers, Binder

Dissolution tester, ERWEKA

Spectrophotometer, General Electric

Capsule filling desk machine,

ProFill 3007

Tablet press,

RIVA PICCOLA TABLET PRESS D-8

Tablet and capsule coating laboratory machine,

Labcoat M (LC M), O*HARA

Semi-automated desk blister, mod., In-Pack HITEMA

Humidity analyzer,

SARTORIUS AG, MA45

Fluid bed laboratory unit,

Solidlab 2

Hüttlin

Tablet disintegration control tester,

Erweka

TBH210 tablet hardness determination tester, Erweka

Tablet friability control tester,

Erweka

Cabinet mod. VD53 vacuum drying chamber, BINDER

ERWEKA AR 402 universal drive, with accessories for milling, blending and calibrating powders

RESEARCH METHODS

Key approaches to research

Compliance of all stages of the pharmaceutical development with ICG and Q8

Continuous monitoring of the current level of requirements for the quality of medicines set by the leading international organizations, foreign and national pharmacopeia, regulators of the Ministry of Health of the Russian Federation to ensure the competitive ability of the drugs at the pharmaceutical development stage

Use of chromatographic control methods during development, validation of analytical methods, application of modern trends and approaches to the development of new drugs and the reproduction of reference drug formulations

 

OUR TEAM

14

associates

3

candidates of science

33

years average age

Natalya Nikolaevna Elkova

Candidate of Chemistry

Head

Elena Alexeevna Rogozhkina

Candidate of Chemistry

Head of Analytical Department

Laima Arturovna Gribovskaya

Head of Technological Department

Olga Alexandrovna Lesnykh

Head of Standardization Group

Natalya Georgievna Rakova

Logistics Manager

Vladimir Ivanovich Pokryshkin

Head of Medical and Experimental Group

HISTORY

Who we are, what we do and what we believe in

The IRWIN 2 OOO medicines development and registration center was established on May 14, 2014 to develop and register drugs under the Pharma 2020 import substitution program, and to increase the production of socially important domestic drugs

We believe that through the implementation of the Pharma 2020 program people will gain unfettered access to reasonably priced vital medicines in every region of the Russian Federation

To achieve the above goals, in 2015-2016 it is planned to increase the number of laboratory employees to 23

PRIMARY RESULTS

We draw inspiration from our results

In the short period of time since the laboratory was opened, we have achieved the following results:

01

The formulation and manufacturing technology for five (5) generics have been developed

02

4 (four) generics have been transferred to the production site of ZiO-Zdorovie ZAO

03

The registration dossier for one (1) generic has been developed

PUBLICATIONS, GRANTS

We are a young and fast growing scientific team. We plan to issue a number of publications in the near future. Besides this, we take part in national programs to search for and obtain grants for the development of domestic drugs

CONTACTS

Contact phone number: +7 495 725 44 68

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