Norme de certification: Conforme aux normes pharmacopées/réglementaires applicables (USP/EP/GMP) ; documentation disponible sur demande
Application: BioPharma — soutient les flux de développement/fabrication biopharmaceutique tel que décrit
Pays d'origine: Disponible sur demande ; le prestataire opère selon la juridiction GMP régionale
Statut réglementaire: Réalisé selon des systèmes qualité conformes aux BPL/BPF, conformément aux directives ICH
Type de formulation: Portée du service/de la plateforme adaptée au type de molécule du client (petite molécule, biologique, ADC, thérapie cellulaire/génique)

Autres informations

Description supplémentaire:

For businesses that know which biopharma solution they need and want the right delivery partner, Caldic offers the expertise to source, process, and customize packaging to exact requirements - from packaging and single-use solutions to stainless steel vials - while meeting allergen, GMO, or REACH regulatory requirements. Caldic's experts guide customers to products and services that perform within strict rules and regulations, recognizing that speed to market is central to success, and bring an agile, entrepreneurial approach to go the extra step toward achieving customer goals. As a value-add partner, Caldic's services include adherence to current Good Manufacturing Practice and Good Distribution Practice specifications, supported by a network of reliable global partners for sourcing high-quality biopharma ingredients, with the flexibility to meet each customer's specific challenge.