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4416 Bubendorf - Switzerland Torrance, CA 90505 - USA Tokyo 108-0075 - Japan
Tel +41 58 595 2021 Tel +1 888 422 2436 Tel +81 3 4405 3141
Fax +41 58 595 2040 Tel +1 888 4BACHEM Email sales.jp@bachem.com
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CLINALFA® PLUS

Clinalfa® Plus

Clinalfa® is Bachem’s brand for its clinical trial materials and related services. Clinalfa plus products are sold exclusively to “Authorized Persons and Companies”.

 

Clinalfa® plus products are available as sterile freeze-dried products or as ready-to-use liquid formulations. The products are manufactured and released based on the requirements laid down in the European Commission Directives 2001/20/EC and 2003/94/EC and the EU GMP guide including annex 13. The products contain active substances manufactured and released according to ICH Q7.


Clinalfa® plus products can be used in pre-clinical or clinical studies (clinical trials) provided that such clinical studies fully comply with the international ethical and scientific standards as stated in the ICH guideline for Good Clinical Practice E6 (R1).


Clinalfa® plus products are manufactured and released on a customized basis. Based on agreements between the customer and Bachem, Bachem’s Qualified Person (QP) may relate the release of the products to the use in a specific clinical trial approved by the competent authority. For Clinalfa® plus products the level of validation of the manufacturing process and analytical methods, the design and duration of post-release stability studies and the content of CMC documentation is customized based on the developmental stage and intended use of the products.


Clinalfa® products are manufactured and released by Bachem Distribution Services GmbH, Weil am Rhein, Germany. Please have a look at the respective manufacturing license and certificate of GMP compliance. For offers and supply of Clinalfa® products and Clinalfa® services, the General Conditions of Sale of the Bachem Group apply.