BASF’s quality and regulatory pharma solutions team offers a global and regional presence with a decades-long track record of successfully enabling our Pharma customers to register finished drug products worldwide. With RegXcellence® you can simplify the compliance process and gain access to regulatory documents, statements and audit information. With more than 75 years of expertise, BASF offers the continuity and experience to provide solutions for your pharmaceutical business to succeed now and in the future.
If you need compliance documentation, your Virtual Pharma Assistant is there, whenever and wherever you need it.
Use RegXcellence® to simplify the compliance process. Instantly access documentation & more!
With quality at the forefront of our mission, we are excited to announced that our plant in Holthausen, Duesseldorf is now EXCiPACT® certified. Functioning as a third party, EXCiPACT asbl is a non-profit organization that owns and manages oversight of such an independent, high-quality Certification Scheme which is available to pharmaceutical excipient manufacturers and distributors worldwide. As an EXCiPACT® certificate holder, BASF is a reliable source that offers access to audit reports and certificates to simplify the supplier qualification process.
BASF’s dedicated quality team ensures the implementation of uniform standards and processes for our production sites and all products worldwide, as well as compliance with all relevant statutory requirements.
Third-party audit reports for excipients or APIs products are available and digitally accessible in RegXcellence®️. We meet the needs of your business via worldwide registration and submission support from accompanying documents to full dossiers.
BASF production sites are inspected by relevant health authorities and have been granted GMP certificates for APIs and excipients as applicable. Third-party audits for individual excipients or APIs products are available at RX-360, Rephine, Excipact and Intertek.
