Quality

Allergon is certified according to ISO 9001:2000 to assure you that your products meet the requirements imposed. We have been inspected by the FDA and comply with Code of Federal Regulations. We assist our customers with product references and supply Site Master File on request to the authorities. Allergon has long experience of the authorities’ requirements and will be pleased to help.

We comply with CGMP, and are inspected continuously in accordance with the ISO 9001:2008 standard.

Regulations to follow:

• The European Pharmacopoeia monograph Allergenic Product
• The US Code of Federal Regulations, with respect to allergenic source material
• The EMEA Note for guidance