Q&A and Regulatory Compliance
Corena Therapeutics GmbH is committed to high quality in all its functions. Our goal is to exceed the expectations and provide them with skin care tips in order to improve their quality of life.
The company is having strict Contract Manufacturing Agreements with the facilities executing Good Manufacturing Practices (GMP) system. All steps from production of bulk and bottled in the finished package are documented in accordance with legal guidelines and the various ISO Standards (ISO 9001, ISO 13485, ISO 22716). Systems are already in place and ready for auditing.
FOPH Authorization No. CHZN4384
As a pharmaceutical wholesaler, we guarantee a safe, complete and traceable supply chain by:
Validation: We work with validated suppliers, fully licensed by the Health Authorities.
Storage: Our partner is one of the leading pharma logistic service provider in Switzerland, (working under GMP and GDP compliance). They are specialized in temperature-controlled shipments, providing validated boxes, data loggers and a precise traceability of the package from the starting point to the final destination.
Monitoring: We can track and capture any data regarding the products we handle. This includes recording lot numbers, expiry dates and temperatures for security and in case of a product recall.
Regular Internal Audits are done by our internal QP, as well as by Swiss Health Authority’s representative.
Swissmedic Authorization No. 510364