Your Regulatory and
Quality Partner
Lichtblau GmbH: Your reliable partner for market access and quality in pharma, medical devices, and diagnostics.
About us
We provide comprehensive support in creating and reviewing your (common) technical documentation for legally compliant conformity assessments and CE marking according to IVDR and MDR as well as for pharmaceutical product approvals. Furthermore, we assist your global market access through the professional preparation of international registration dossiers.
We offer extensive experience in change management and its regulatory processes, as well as in the fields of quality management and quality control.
Our expertise ensures your success in a dynamic market. We provide the necessary operational support to efficiently bridge short- or long-term staffing shortages in your day-to-day business.
Expert Support
Our hands-on experience allows us to cover a broad spectrum of application areas