Quality assurance

Full traceability is guaranteed and information is securely stored in our archiving system.

 

We are approved for the manufacture of API from preclinical through to commercial supply.
In-house manufacture is carried out according to cGMP under a comprehensive quality management strategy.

 

Our Quality Management System focuses on quality management, documentation and records, materials management and laboratory controls, and is based on the principles described in the ICH Q7A guidelines.

 

SONEAS Research defines five in-house GMP-levels , and the level applied to a project is determined by the clinical development phase of the API and whether the compound being made is a starting material, intermediate or API. A copy of our SOP in relation to this, or a summary of how we define these levels, is available on request.

 

SONEAS Research also qualified according to ISO 9001:2008 requirements and has successfully passed Kosher and Halal audits required by F+F industry

 

SONEAS Chemicals operates under ISO 9001 : 2008 qualification and successfully passed Kosher audit.

 

Clients regularly visit our facilities for formal or informal audits, and we are happy to provide detailed information in relation to our quality systems.

 

Our quality systems and procedures are proven to deliver product suitable for clinical trials, giving our clients the confidence that their development projects will remain on-track.

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