The Regulatory Affairs staff, supported by our Scientific Advisory Board, can provide you with opinions on the regulatory impact of Aseptic Technologies’ products.

The regulatory staff also communicates frequently with regulatory agencies so they have a thorough understanding of the various agencies' positions as they relate to Aseptic Technologies and its customers' products.

Click on the links below to read some of the most relevant industry guidance’s :

• Current Good Manufacturing Practice for Finished Pharmaceutical
• Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practices
• Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics
• EudraLex, Volume 4 of “The rules governing medicinal products in the European Union”

To intensify the information exchange with the manufacturing pharmaceutical industry and also to present and discuss our innovations, we closely work with various institutions, such as:

Parenteral Drug Association (PDA)

International Society for Pharmaceutical Engineering (ISPE)