In Rolabo we deliver the highest purity APIs with full regulatory compliance/support.

Quality Assurance

Our manufacturing plant is regularly visited and audited by partners. Working under strict cGMP guidelines, we are regularly audited by major World Health Authorities (USA, Spanish, European, Korean, etc.).

Rolabo FDA last inspection: October, 2006

Our QA / Regulatory Affairs departments have a long established experience and are up to date with the latest guidelines (CTD DMFs, LoAs, MRPs, deficiency letters, etc...) providing full support to our partners. We have filed our DMFs with major world Health Authorities and CEP have also been granted to Rolabo´s major products.