QuALITY &Â CERTIFICATIONS
Genova Biosciences prioritizes rigorous quality assurance. Our manufacturers adhere to strict global standards, backed by independent certifications to ensure total regulatory compliance.
GMP, cGMP and WHO GMP
Documented, repeatable manufacturing under controlled conditions, with auditable batch records.
EXCiPACTâ„¢ and IPEC-PQG
Quality schemes written specifically for excipient manufacturing rather than for finished drug product.
Pharmacopoeia compliance
Material meeting the published monograph in your filing territory.
US FDA recognition and Drug Master Files
FDA registration, and DMFs your submission can reference.
quality
compliance
The standards that govern manufacturing and support regulatory submissions.Â
quality
certificates
acquired
Third-party marks, held and maintained by
the manufacturers.
certifications
ISO management systems
For quality, environment, occupational safety, energy and food safety.
Food safety: FSSC 22000, HACCP, GFSI, HARPC
What makes the portfolio usable for all markets.
Kosher
Independently certified Kosher status.
Halal
Independently certified Halal status, including MUI Halal.