Europe/Asia USA
Bachem AG Bachem Americas, Inc.
Hauptstrasse 144 3132 Kashiwa Street
4416 Bubendorf - Switzerland Torrance, CA 90505 - USA
Tel +41 61 935 2323 Tel +1 888 422 2436
Fax +41 61 935 2325 +1 888 4BACHEM
E-mail sales.ch@bachem.com +1 310 539 4171
  Fax +1 310 539 9428
  E-mail sales.us@bachem.com

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.