We are committed to providing products of the highest quality, and we are proud to have successfully passed inspections by competent local authorities and the U.S. Food and Drug Administration (FDA). Additionally, we regularly undergo audits by our customers. Our efforts have resulted in the Establishment Inspection Report (EIR) by the FDA and in the issuance of the certificates by national authorities as mentioned below.
We also conduct regular evaluations of our suppliers to verify compliance with European and global regulations and prevent possible non-conformances.
We guarantee that all our products and services comply with applicable legal regulations in the Federal Republic of Germany, international regulations, and standards, as well as the requirements and provisions of all contracts with local and international partners.
- Certificate Of GMP Compliance And Manufacturing Authorization For Production Of Radiopharmaceuticals
- Certificate Of GMP Compliance As IMP (Investigational Medicinal Products) Manufacturer
- Certificate Of GMP Compliance As API (Active Pharmaceutical Ingredients) Manufacturer
- DIN EN ISO 134852016 Standards
- Registration Certificate Of Foreign Medical Device Manufacturer In Japan