Clinalfa® is Bachem’s brand for its clinical trial materials and related services. Clinalfa basic products are sold exclusively to “Authorized Persons and Companies”.
For a free copy of our brochure Clinalfa® - Clinical trial materials from Bachem click here.

Clinalfa basic products are sterile freeze-dried products in individual glass vials to be used in approved human clinical studies. The products are manufactured and released based on the requirements laid down in the EU GMP guide including annex 13. The products contain active substances manufactured and released according to ICH Q7.

Clinalfa basic products are not approved drug products, not authorized for marketing and can only be used in human studies (clinical trials) that fully comply with the international ethical and scientific standards as stated in the ICH guideline for Good Clinical Practice E6 (R1). The investigator and/or sponsor shall be fully responsible for the intended use of the Clinalfa products, especially for judging the fitness of the products for such use, and for obtaining all respective legally required authorization. The investigator or sponsor shall also ensure that the documentation taken into account by Bachem’s Qualified Person (QP) when certifying the batch is consistent with the information submitted to the competent authorities for clinical trial approval.

The supply of Clinalfa basic products is accompanied by Bachem’s Certificate of Analysis (CofA), confirming accordance with EU GMP requirements for investigational medicinal products and signed by Bachem’s Qualified Person (QP). Please note:

• The investigator or sponsor acknowledges that human use of the products is limited to approved clinical studies.
• The manufacturing process might not be fully validated.
• The analytical release methods might not be fully validated.
• The products are released against specifications.
• Post-release stability data are available for the freeze-dried product only.
• Post-release stability data are available for a limited post-release time only.
• Bachem is not performing toxicological studies.
• Bachem takes no responsibility for the safety and efficacy of the products.
• Bachem does not take any responsibility for any infringement of any patent(s) covering the application of the product in clinical studies.

On order CMC documentations for the respective active pharmaceutical ingredients (API) and for Clinalfa basic products are purchasable on request. Structure and content of the CMC documentations are based on the requirements laid down in the EMEA guideline CHMP/QWP/185401/2004 final. For further questions, please contact us.

The following products from the Clinalfa basic line are available:

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.

Note. Since July 1, 2007 Bachem is the exclusive owner of the Clinalfa® brand.