In today's world, we are observing a trend of continuous development of GMP standards and, as a result, an increase in the quality and quantity of inspections to pharmaceutical manufacturers.
The organization of the management system of the pharmaceutical production audits, as well as an active approach to prepare the inspection, allow us the safely building and developing of pharmaceutical quality system of a company.
Our team is formed by experts with experience in inspections carried out by the regulatory bodies of the Russian Federation, Kazakhstan, Belarus, as well as PIC/S and WHO. The result of our work includes more than 300 GMP audits´ reports and more than 150 pharmaceutical companies´ consultations.
Our services
- Performance of GMP audits prior to inspections;
- Review, analysis, development of documentation in all stages of GMP inspection.;
- Advising on compliance with GMP requirements in order to successfully pass GMP inspections;
- Carrying out the training for the personnel of the production site in the important aspects to successfully pass the GMP inspections;
- Professional translation of documentation and interpretation in all stages of GMP inspection.
Advantage
- Extensive experience of participation in the inspections and assessments of the manufacturer in the preparation stage of the documents.
- Knowledge of the specific aspects of the legal requirements of the Russian Federation, Kazakhstan, Belarus and the EU.
- Active communication with representatives of regulatory bodies and organizations responsible for inspections.
- Application of the audit procedures similar to those used by the regulatory body during the inspections.
- Optimization of time dedication taking into account the preferences of the manufacturer during the provision of the services.
Our customers are manufacturers or their authorized representatives who are planning to receive an inspection at their production site of pharmaceutical substances, intermediate products and finished pharmaceutical products, including medicines for human use and veterinary use.
Our goal is to improve the pharmaceutical quality system of pharmaceutical companies for the subsequent successful passage of GMP inspections.