Method development and validation

Whether it concerns the design of a new method or the improvement of an existing one to bring it in line with the latest technology, method development has many facets. Often, regulatory updates or changes will necessitate the development of methods.

Method development

On behalf of our clients, Diapharm Analytics, a Tentamus company, develops concept-based scientifically sound and cost-effective analysis methods. The pharmaceutical laboratory also drafts development plans and reports, testing instructions, and validation plans and reports.

The transfer of methods to clients or third parties is supported with coordinated method transfers. Diapharm Analytics also provides coordinated project management, drawing on external qualified partners as required.

Method validation

To gain marketing authorisation or registration of a medicinal product, the validity of test methods has to be demonstrated. Diapharm Analytics assists clients in creating appropriate validation plans and validating methods in accordance with ICH guideline Q2(R1). If the need arises, the company also manages the transfer of methods to routine laboratory analysis, including the drafting of transfer plans and reports.

As a matter of course, Diapharm Analytics also offers adequately customised validations for related product categories, such as food supplements, cosmetics or medical devices.

Using validated and robust methods brings reliability to your routine processes. At the same time, it gives you the necessary scope to manoeuvre, when flexibility is required.

Photo:  Nicole Lübben
Nicole Lübben
Senior Manager Laboratory · Diapharm Analytics
Photo:  Steve Ross
Steve Ross
Manager Laboratory · Diapharm Analytics
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