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„WESSLING guarantees entry to the EU market for your finished product”

Pharmaceutical testing

The Pharmaceutical Testing Laboratory of WESSLING Hungary Kft. is an independent European Batch Control Site with a GMP Certificate.

The Pharmaceutical Testing Laboratory of WESSLING Hungary Ltd. performs analyses of pharmaceutical finished products and raw materials. During the investigations special attention is paid to product safety, drug stability and retesting of pharmaceutical products from third countries.

Analyses are performed according to the analytical testing procedures provided by the customers or current Pharmacopoeias (Ph.EUR, USP etc.)

Certificate of Analysis According to the Product Quality Test Specification

Stability studies:

We are able to store the samples under GMP conditions at different climate zones according to ICH guidelines, perform analytical tests at each stability point and prepare the corresponding documentation.

Validation of analytical methods - Technology transfer

If required, we can develop analytical methods and then validate them according to guidelines and customers wish.

If a validated method is intended to be transferred to our laboratory the following options are available:

Direct method transfer
Indirect (collaborative) method transfer
Analytical method revalidation

Transferred molecules

 

WESSLING HUNGARY Kft.

1045 Budapest, Anonymus u. 6.
Tel.: 06 1 872 3600
Fax: 06 1 435 0100
www.wessling.hu

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