CERTIFICATIONS OF OUR PRODUCTION SITES
GMP Part II certification (API) by the french ANSM
FSSC22000 certification
FDA approval
Responsible Care certification
HALAL and KOSHER certifications
Our production sites are regularly inspected by authorities and customers. We are also proposing grouped audits by third party companies.
PHARMACEUTICAL DOSSIERS
Most of our API (pharmaceutical actives) have a complete regulatory file :
- deposited CEP or DMF
- property CTD (common technical dossier)
- ICH stbility studies
REGULATORY
Our ingredients are compliant with all régulations related to the served applications. They are certified without GMO, allegens, CMR…
Our raw materials, except in particular cases, are sourced in Europe and our raw material suppliers are approved and audited by our Quality team.
In addition, most of our ingredients (when applicable):
- are COSMOS certified
- are REACH Registered/compliant
- are suitable for VEGAN
ENVIRONNEMENT AND CSR
ISALTIS plants are respecting the Green Chemistry principles, and are committed to reduce their environmental impact by regular action plans.
CSR (Corporate Social Responsibility) is also an important criteria for ISALTIS.
Please contact us for more details at contact@isaltis.com
