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GMP CONSULTING

FAVEA-Center has 20 years of experience in implementing GMP standards, both at the production sites of the European Union and the CIS countries. Over the years of our work, we have designed more than 200 and built more than 50 pharmaceutical plants on a turnkey basis. Including the production of immunobiological, hormonal and cytostatic drugs using technology transfer.

In order to support pharmaceutical manufacturers, banks and investment organizations, we provide technical and technological consulting, evaluation of investment pharmaceutical projects, audit of production sites, as well as training of specialists of pharmaceutical companies.

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FAVEA-Center provides the following range of services:

 

  • Technical and technological evaluation of projects in terms of the possibility of their implementation

  • Analysis, evaluation of the production portfolio and compatibility of planned products, including analysis of OEB/OHC toxicological groups

  • Risk Analysis and Assessment for Cross-Contamination, Qualification and Validation (Risk Analysis)

  • Analysis of the strategy and approaches to conducting validation at the enterprise (Validation Master Plan)

  • Examination of projects in terms of compliance with GxP requirements (Design Qualification, DQ)

  • Audit of existing production enterprises with the issuance of recommendations for modernization in accordance with GMP standards

  • Training of enterprise personnel on GxP good practices (more than 300 topics): corporate and open seminars, webinars, e-learning E-learning

  • Consulting on the organization of production, qualification and validation in accordance with applicable law

  • Assistance in transferring, scaling or improving pharmaceutical technologies

Video lecture "Technical solution for standard and cytostatic products

We are in touch

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