cGMP compliant documentation

Deliverables comprice product and product documentation including a Certificate of Analysis.

Bioneer contract manufacturing is characterized by:

• A production facility approved by the Danish regulatory authorities for fermentation of Bio Hazard Class I and Class II microorganisms.
• A well-defined production area with restricted access to minimize the risk of cross-contamination.
• Production equipment which is fully qualified in compliance with GMP requirements.
• Well-documented cleaning and testing procedures.
• Written procedures for in-process quality control (QC) and QC testing of final product.