Trusted Standards

Trusted Standards

Our commitment to quality and compliance

Quality & Compliance

For more than a century, we have supported public health through the development and manufacture of vaccines. Our accreditations, certifications and licences reflect the quality standards, regulatory oversight and operational excellence that underpin this work every day.

Regulatory Compliance

Adhering to the highest standards for clinical trial and service operations

Quality System

Quality System

Documented processes and procedures for IMP manufacturing, testing and distribution within our comprehensive quality system.

EU Compliance

EU Compliance

Regular IMP release for European clinical studies according to Annex 13 and EU Clinical Trial Regulation.

BSL 2/3 Facility

BSL 2/3 Facility

State-of-the-art biosafety level 2/3 conditions ensuring the highest safety and quality standards for manufacturing.

Accreditations & Certifications

Our accreditations and certifications demonstrate our commitment to quality and compliance

  • Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)
  • BSL 2&3 certified production and laboratory facilitiesBSL 2&3 certified production and laboratory facilities
  • MIA for biological production, production of clinical materials and import of clinical trial materialsMIA for biological production, production of clinical materials and import of clinical trial materials
  • Good Manufacturing PractiseGood Manufacturing Practise
  • Good Distribution PractiseGood Distribution Practise
  • ISO 9001ISO 9001
  • ISO 14001ISO 14001

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