Comparability Testing

Providing knowledge on comparability for your projects 

Confidence in the quality, safety, and efficacy of your products

Comparability testing is a crucial aspect of the pharmaceutical industry, particularly in the development of biosimilars and biologics. It involves assessing the similarity between two products, typically a reference product and a test product, to ensure that they are highly comparable in terms of quality, safety, and efficacy.

The purpose of comparability testing is to demonstrate that any changes made to a manufacturing process, formulation, or other critical parameters do not have a significant impact on the quality and performance of the product. It is an essential step in regulatory submissions and is typically required by regulatory authorities such as the FDA and EMA.

Profarma recognizes the importance of comparability testing and offers comprehensive support in this area. Our experienced team of scientists follows established guidelines and regulatory requirements to design and conduct comparability studies.

Comparability testing

Our services include:

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