Company


The core of our team consists of professionals, who have stood at the origins of the pharmaceutical quality system for production of solid dosage forms, in accordance with the GMP/GDP requirements, and have maintained this system for more than 10 years.
We are a growing consulting company which is engaged in drug manufacturing and which provides a full range of services for companies wishing to do business and to keep abreast with the cutting-edge global trends and requirements (GMP/GDP). We are holding ourselves as a responsible company, striving to take rational, economically beneficial and quick decisions. Today, the principal business lines of our company embrace the development and the implementation of the quality system for both producers and distributors of pharmaceuticals, follow-up / handling of a set of operations for the validation and qualification, drafting and updating the documents needed for a successful operation of companies on the pharmaceutical market of the CIS.

WHERE WE ARE DIFFERENT:

- more than 10 years of hands-on experience in the field of drug manufacturing;

- extensive knowledge and practical experience in finding a reasonable trade-off between the regulatory requirements and the economic expediency;

- provision of a full scale of high-grade services to our customers, with an ability to find a solution for any issue you might have;

- centralized project management;

- a desire to share our expertise with others.

Our team

All projects and services, provided by our company, are realized under a close surveillance of seasoned GMP/GDP professionals.

LEAD GMP/GDP CONSULTANT

ELENA ZIMINA

LEAD GMP/GDP CONSULTANT

- PhD in pharmaceuticals
- operational experience is more than 10 years
- authorized person /Quality director
- successful experience in development (from scratch), implementation and maintenance of the pharmaceutical quality system in accordance with the European requirements (LLC “Pharma Start”)
- experience in holding workshops in the CIS countries

PROJECT MANAGER, GMP/GDP CONSULTANT

YAROSLAV LEBEDEVICH

PROJECT MANAGER, GMP/GDP CONSULTANT

- work experience of above 7 years at a position related to validation and qualification issues, as well as in the capacity of Head of quality control

- theoretical skills and hands-on experience in holding qualification of the manufacturing and laboratory equipment, “clean” and warehouse premises, supplementary systems, validation of technological processes and cleaning validation

- practical experience in maintenance and continuous upgrading of the pharmaceutical quality system

OTHER MEMBERS OF THE TEAM
OTHER MEMBERS OF THE TEAM

- specialists having both theoretical and practical background in various pharmaceutical companies, operating based on GMP/GDP international standards.

OUTSOURCING
OUTSOURCING

Outsourcing – if needed, engaged are only specialized companies, having been pre-approved and further confirmed to be competent to carry out the necessary works.

Contacts

OFFICE IN UKRAINE

Address: 3 Sholudenko Str., office 210, Office Center “Kubik”, Kiev, 04116, Ukraine 

E-mail: office@bsc-gmp.com
Tel.:   +38 (044) 232 38 32
Cell:   +38 (095) 872 34 23
         +38 (098) 991 90 06
Fax:   +38 (067) 441 54 88

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