Quality Assurance

Consultancy

Healthcare & Pharma

Quality Assurance

Ensuring the quality of your products is essential in life science operations. At Normec, we offer in-depth expertise in quality processes at every level. From setting up quality management systems (QMS) to audit support and risk management, we make sure your processes meet the highest standards and that your products consistently achieve the desired quality.

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Our Expertise

At Normec, we combine extensive knowledge of GxP regulations and global standards—such as Good Manufacturing Practices (GMP), ISO standards, FDA regulations, and the requirements of regulatory authorities like EMA, ANVISA, AIFA, and CFDA—with hands-on experience to support your quality processes. We guide you in setting up robust quality management systems, ensure compliance with applicable laws and regulations, and provide operational support in executing quality processes.

Our experts make sure your systems are always aligned with the requirements, from managing deviations to performing risk management.

We support companies with:

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Compliance management

We assist in managing deviations, changes, and CAPAs, ensure regular updates of system documentation, and prepare detailed trend reports.

Audit Support

From gap assessments of processes and quality systems to implementing action plans and guiding you through the audit itself, we ensure you are 100% prepared for inspections.

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Quality Management Systems (QMS)

We provide support in setting up QMS according to GMP standards, optimizing existing systems, and implementing electronic QMS solutions. This also includes drafting procedures, work instructions, and documentation, as well as offering operational support.

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Risk Analysis

We conduct structured risk analyses (e.g., FMEA) and implement measures to minimize risks. All risk management processes are thoroughly documented, and we offer training sessions on how to perform risk assessments.

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Technical QA Support (Technical Compliance Support

We provide hands-on and repetitive support for tasks such as deviation management, maintenance of quality management systems (QMS), Periodic Quality Reviews (PQR), and more. This allows your team to focus on core business activities, while we take care of administrative optimization and execute routine tasks with the highest precision and efficiency.

Discover how we can optimize your quality processes

We help you optimize your quality processes to meet the strict requirements of the Life Sciences sector and regulatory standards. Whether you need support with compliance, risk management, audits, QMS, or technical QA, our experts are ready to ensure your success.

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