Quality Policy

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53Biologics considers that quality is an essential factor for the success of the organization and therefore the quality and environmental policy is based on a firm commitment to customers to fully satisfy their requirements and expectations. To this end, we guarantee to promote a culture of Quality and Environment by adopting the most demanding international standards.


We work to achieve excellence in our services as a CDMO and collaborate in the achievement of our clients’ goals.

We are committed to our values (flexibility, integrity, passion and transparency) to build strong collaborative relationships. Our commitment leads our day-to-day work and opportunities for improvement.

We are proud to have a multidisciplinary and motivated team of scientists with extensive experience in all stages that bring value to biopharma processes.


We apply the latest techniques and knowledge in our entire portfolio of services (DNA plasmids, RNA generation and purification and protein production).

We are aware of the needs of our customers, and therefore we apply the most advanced techniques in all our processes.


We are committed to the legal and environmental aspects that apply to our processes.

We work with the highest quality standards (GMP, GCP, GLP), to ensure compliance with all legal requirements, make responsible use of natural resources and appreciate that our suppliers operate with the same standards of conduct.


We work according to world-class standards.

Our processes are approved by regulatory agencies in the USA (FDA) and Europe (EMA), which allows us to better serve our international customers.

Management makes this policy accessible and available to its customers, all employees, suppliers and the general public. The Integrated System is also kept up to date through regular reviews, which include a management review to take into account changes in environmental conditions, objective data on its application and feedback.