IVD development and assay design
Scientific support from concept to market readiness: assay design, method and procedure validation, analytical performance evaluation and LC-MS/MS based clinical diagnostics.
In-vitro Diagnostics · Berlin · International
Consulting for the development of medical in-vitro diagnostics
Scientific. Regulatory. Clinical.
Andromedica Consulting supports manufacturers of in-vitro diagnostics and pharmaceutical companies from assay concept to market authorisation, drawing on more than 20 years in clinical laboratory medicine, industrial platform development and international regulatory procedures.
Core competencies
Three areas where IVD projects most often fail
Analytics, regulatory affairs and clinical evidence are interdependent. Planning any one of them in isolation is expensive to correct later.
Regulatory consulting
EU IVDR, FDA procedures and conformity with ISO 13485, 15189 and 17025: classification, technical documentation and the Performance Evaluation Report under Annex XIII.
Companion diagnostics
CDx strategy for personalised medicine and biosimilar programmes: choosing the diagnostic route, aligning drug and device approvals, and improving analytical performance.
Experience in numbers
Practice, not theory
Built in the clinical laboratory and in mass spectrometry, tested in international matrix organisations across three continents.
20+
Years of experience
200+
Staff led
400+
Certified assays
3
Continents
How I work
What a collaboration looks like
Clearly bounded steps, mostly remote, with defined deliverables instead of open-ended hours.
01
First call and orientation
30 minutes at no cost: where the product stands, which regulatory class is realistic, which evidence is missing. The outcome is an honest estimate of the effort involved.
02
Assessment
Review of existing data, documentation and processes, and identification of the gaps that stand in the way of a conformity assessment or a submission.
03
Implementation
Joint work on study plans, validation reports, technical documentation or CDx strategy, either as a defined project or as a fixed weekly capacity from 10 hours.
04
Support through approval
Support in communicating with notified bodies, authorities, reference laboratories and clinical partners, up to market authorisation and beyond.