IVD Development & Assay Design
Scientific guidance for the development of in-vitro diagnostic systems, assays, and LC-MS/MS-based clinical tests from conception through market readiness.
IVD Development Consulting
Scientific. Regulatory. Clinical.
Andromedica Consulting supports companies in the in-vitro diagnostics and pharmaceutical industry with the development, approval, and market launch of diagnostic systems – from assay conception to FDA and EU approval.
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Over 20 years of experience in clinical diagnostics, laboratory medicine, and the IVD industry
Regulatory Consulting
Support with EU IVDR, FDA approvals, and compliance with international standards (ISO 13485, 15189, 17025) for seamless market approvals.
Companion Diagnostics (CDx)
Strategic and scientific consulting on companion diagnostics in the context of biosimilar development and personalized medicine.
Experience in Numbers
20+
Years of Experience
200+
Team Members Led
400+
Certified Assays
3
Continents