Quality Systems Development

In the Pharmaceutical, Biotechnological and Cosmetic sectors, as well as in Medical Devices, food and others, it is of vital importance to implement and develop robust quality management systems that provide the necessary guarantees for the development, production and control of effective and safe products to the patients they are intended for. Continuous Improvement within the organization, throughout the product lifecycle, in permanent compliance with current regulations should be ensured.

At TDV we offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems. We are always aiming the same target: to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product. And, of course, with the right consideration of the applicable regulatory requirements and national and international guidelines.

As experts in Quality Systems, we offer at TDV services such as:

Project management for development/implantation of quality systems for new plants, processes and products.
Evaluation of regulatory and quality requirements applicable to each industry/process.
Advice on the definition or optimization of the structure of the quality unit and the distribution of responsibilities.
Quality System Internal Audits and Definition of the associated Action Plans.
Writing or updating quality system documentation: Policy, Quality Manual, Standard Operating Procedures (SOPs), etc.
Systems and Processes Risk Analysis.
Support and technical assistance in quality areas (Batch Review, Deviation and Layer Management, etc.)
GxP compliance and inspection preparation. Click here for more information.

For more information on Quality Systems Development contact:

Mª Àngels San
masan@tdvct.com

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Case Studies

  • ISO 13485

    Quality System based on ISO 13485:2016

    Project scope: Provide consultancy and technical assistance for the development of the Quality Management System (QMS) based on ISO 13485 for the design, development and commercialization […]