Xcipharm®
The all-inclusive excipients
The marketing of a new medicine is a long and complex process that requires exemplary record keeping. This exemplary record-keeping is also required by the authorities for all or part of the supply chain of the various Raw Materials for Pharmaceutical Use.
CARLO ERBA Reagents has specifically created the Xcipharm® range dedicated to excipients in order to help you in your regulatory procedures. We follow the IPEC 2015 guide (GMP and GDP) and we can deliver the following documents:
- ICHQ3D
- Residual solvents
- GMO certificate
- BSE/TSE
- Stability study
- Certificate of Analysis
- Supply chain and risk management
- QMS certifications
These documents as well as other elements such as packaging traceability, label reconciliation, product declaration to the ANSM are INCLUDED in our pricing proposals when you choose our Xcipharm® range.
Download the brochure dedicated to Pharma Industry