Excellence in quality and compliance through expert, data-driven solutions

Quality

Enovalife ensures a high level of quality in our clients’ products, aligning with product specifications and regulatory requirements in the countries where products are released.

Our assets

1 / 2

Quality assurance expertise

Broad knowledge of regulations related to product specifications:
- Tailored QA models for pharmaceutical products, biologics, food products, medical devices, and healthcare products
- Deep understanding of market-specific regulatory requirements
Extensive expertise across the entire manufacturing process, enabling us to identify critical steps and focus the QA strategy accordingly
QMS (Quality Management System) implementation and customization, supported by a comprehensive approach to QA strategy
Expertise in various QA areas, including R&D, clinical trials, supplier management, QC, and validation (CSV, CQV), as well as manufacturing
- Skilled in audit preparation
- Proficient in QA-specific tasks such as SOP writing, deviation management, CAPA implementation, and batch release with a lean management perspective
Lean expertise from green belt to black belt levels, enhancing our QA solutions

Analytical development and quality control expertise

Broad knowledge of analytical development and quality control processes
- Expertise in developing, validating, and transferring diverse analytical methods
- Skilled in both hands-on manipulation and strategic modeling
Experience with a wide range of methods, including physicochemical, chemical, microbiological, and biological techniques
Familiarity with working on incoming materials, semi-finished products, and finished products
Ability to tailor strategies to meet specific quality and field requirements
Strong understanding of the interactions required across departments and adaptability to their specific needs
Extensive experience with necessary documentation
Expertise in stability studies

Why choose us?

Trusted partner

Enovalife has been a trusted partner to major pharmaceutical companies, supporting their Quality Assurance management in recent years.

Tailored expertise

We provide comprehensive, end-to-end support tailored to your needs, thanks to our team’s deep knowledge of GMP, as well as current EU and FDA standards.

Enhance your quality processes through Data & AI

With our expertise in Data & AI, we offer innovative solutions to optimize your quality processes. We develop software utilizing data visualization, artificial intelligence, and data governance, delivering tailored solutions for operational needs.

Life Sciences

Data & AI

Service Centers

Company

Recruitment

Quality

Quality

Our assets

Quality assurance expertise

Analytical development and quality control expertise

Why choose us?

Life Sciences

Data & AI

Service Centers

Company

Recruitment

Navigation level 2

Quality

Quality

Our assets

Quality assurance expertise

Analytical development and quality control expertise

Why choose us?