KLEVA is accredited with an ISO 9001:2015 and a EUGMP certificate.
Quality management is the cornerstone of KLEVA’s business. Our commitment is to offer the most advanced Quality System through a continuous and in-depth monitoring of the pharmaceutical regulatory environment.

KLEVA is accredited with an ISO 9001:2015 and a EUGMP certificate.
Quality management is the cornerstone of KLEVA’s business. Our commitment is to offer the most advanced Quality System through a continuous and in-depth monitoring of the pharmaceutical regulatory environment.

At KLEVA, the objective is to achieve always Quality Excellence. This is achieved by:

  • Maintaining the highest quality standards
  • Continuous improvement of all aspects of the Quality System
  • Employing highly experienced scientific personnel with vast knowledge of the regulatory requirements

Everything is designed in order to achieve the best product quality. The goal is to go beyond regulatory compliance and to proactively anticipate every future regulatory requirement. This is achieved by continuous training the team of the highly experienced and qualified personnel of the Quality Assurance department.

In a very demanding area, as is the Pharmaceutical industry, Quality in
KLEVA is first priority. As a policy, no quality compromise is acceptable in
any aspect of the pharmaceutical development.
Process optimization and Quality by Design are fully incorporated in the
manufacturing process, in order to mitigate process variability and maintain
the highest quality performance and risk management approach to ensure
the quality of the finished products, including ICH Q3D and Nitrosamines
Risk assessment.
KLEVA’s has been successfully audited by customers and regulatory
authorities worldwide, showcasing its high quality standards.

In a very demanding area, as is the Pharmaceutical industry, Quality in
KLEVA is first priority. As a policy, no quality compromise is acceptable in
any aspect of the pharmaceutical development.
Process optimization and Quality by Design are fully incorporated in the
manufacturing process, in order to mitigate process variability and maintain
the highest quality performance and risk management approach to ensure
the quality of the finished products, including ICH Q3D and Nitrosamines
Risk assessment.
KLEVA’s has been successfully audited by customers and regulatory
authorities worldwide, showcasing its high quality standards.

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