Permits / Qualifications

All procedures of our Quality Assurance Systems according to GMP, GDP, DIN EN ISO 9001 and DIN EN ISO 13485, as well as the SOP’s, guarantee a continuous tracking and tracing system for all merchandise movement.

In this manner we can guarantee the highest safety standards in conjunction with audited carriers, as is imperative when handling medicines - both internally and externally.

Our Permits

• Wholesale permit acc. to § 52a, Section  Abs. 1 AMG (german)
• Production permit acc. to §13, Section 1 AMG
• Certificate for Management System acc. to
  - DIN EN ISO 9001 (2000) and
  - DIN EN ISO 13485 (2003)
• BtM Handling Permit
• Import § 72, Section 1 AMG

Within the framework of our self inspections carried out several times each year our control processes are also optimized in keeping with the requirements of our clients so that we can ensure smooth functioning processes at all times.