Expertise Validation & Testing Validation & Testing

Validation & Testing

Patient safety is at heart of our business, always meeting quality demands and complying with legislation. Agidens is your valuable validation partner in the handling of GMP/GLP/ISO projects. Together we ensure that you remain within the guidelines and standards in force.

Agidens contributes to patient and consumer safety in close cooperation with its clients. With more than 25 years of experience in Pharma, Hospitals & Biotech, our Validation & Compliance consultants combine technical advice with sustainable solutions – always in line with current law and legislation.



Demonstrate compliance

Global regulatory agencies focus on the entire pharmaceutical supply chain. Manufacturers and distributors are obligated to guarantee that their products get to the patient under the required temperature conditions.

Patient safety & product quality are key

The production process of pharmaceutical products is subject to strict regulations. The law obliges manufacturers to provide documented evidence that the process yields a product that continues to meet the proposed requirements.

GxP guidelines

The GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. An essential part of process validation is demonstrating that the systems used are under control throughout the life cycle.




Validation & Testing

The initial scope comprised of the introduction, replacement or decommissioning of CSV, non-CSV and calibration-only. It ranges from simple basic equipment such as plateshakers till complex qPCR systems.

Lab Qualification at major pharma site

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“By implementing a recipe management and execution system, Akorn now has better control over their production processes, as well as complete flexibility.”

Nico Bielawsk Senior Process Engineer at Agidens

Design & Build of Formulation Suspension Facility

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Validation & Testing

The new manufacturing line at our client is now capable of supplying up to 5 times the output of the first manufacturing line in a worldwide market in the medical devices sector, with very strict regulations.

Design, build & qualification of automated assembly line for medical devices

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Let’s take the first step towards achieving your business goals. Fill out the contact form, and discover how Agidens makes sure that progress never stops.


Life Sciences
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Statistical tools are crucial for process validation

Through relevant experience with statistical methods & analysis, our qualified team will provide you with the proper tools for all the different stages of the Process Validation. We will support you along the Product Life Cycle of process validation, including DOE, sampling plans, capability study, and SPC.
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Data-driven insights with Predictive Maintenance

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Trusted Kneat Service Provider

We’re a trusted Kneat Service Provider. As a Kneat Service Provider we are skilled in the use of Kneat and may provide Kneat-related services, in line with our Kneat Academy Power User 1 certification level.

Completion of Kneat Academy Power User 1 program certifies that we have a strong understanding of Document Templates, Section Group Templates, Approval Templates, and Properties on the Kneat Gx platform. We are able to execute and update these elements for established processes for existing Kneat customers.

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