Compliance commitment
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.
Our Certificates
Please find our certificates available for download below.
Registration Certificate Of Foreign Medical Device Manufacturer
Certificate Of GMP Compliance As MP And IMP Manufacturer
Certificate Of GMP Compliance As API Manufacturer
Manufacturing Authorization For Production Of Human Medicinal Radiopharmaceuticals
Registration Certificate Of Foreign Medical Device Manufacturer
Certificate Of GMP Compliance As MP And IMP Manufacturer
Certificate Of GMP Compliance As API Manufacturer
Manufacturing Authorization For Production Of Human Medicinal Radiopharmaceuticals