Quality assurance.

Quality assurance.

Oversight throughout with responsibilities and process controls included in a Quality Technical Agreement. Committed to operating to the highest quality standards.

– Compliant with ISO 9001 all operations certified
– OHSAS 18001 Safety Management System
– ISO 14001 Environmental Management System
– ISO13485 plus other controlled processes (suitable for Biopharma processing)
– GMP regulations as specified in Quality Agreement
– ISO 7 and ISO 8 clean room area

Oversight throughout with responsibilities and process controls included in a Quality Technical Agreement. Committed to operating to the highest quality standards.

– Compliant with ISO 9001 all operations certified
– OHSAS 18001 Safety Management System
– ISO 14001 Environmental Management System
– ISO13485 plus other controlled processes (suitable for Biopharma processing)
– GMP regulations as specified in Quality Agreement
– ISO 7 and ISO 8 clean room area

Your bespoke process.

Our CDMO capabilities cover process development and transfer, manufacturing, and associated quality assurance and project management.

Expression Systems

Upstream

Downstream

Analytical Development

Quality Assurance

Project Management

More about us.

Learn more about us.

The SEKISUI Advantage
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