Scientific consulting
Assay design and development, method validation, analytical performance evaluation and scientific expertise for LC-MS/MS based clinical diagnostics, including therapeutic drug monitoring, drugs of abuse testing and toxicology.
Services
Consulting across the full IVD lifecycle
From the first feasibility question to post-market surveillance: six areas of work, available individually or as continuous support.
Regulatory support
Guidance through the regulatory process under EU IVDR and FDA requirements: classification, technical documentation, the Performance Evaluation Report under Annex XIII and conformity assessment. Expertise in ISO 13485, 15189 and 17025.
Clinical affairs and medical affairs
Planning and support of clinical performance studies, cooperation with key opinion leaders and healthcare professionals, and communication between medical affairs, development and clinical partners.
Companion diagnostics
Strategic advice on the role of CDx in personalised medicine and biosimilar programmes: the build-or-partner decision, alignment of approval pathways and improvement of analytical performance.
Laboratory strategy and quality management
Strategic direction of clinical laboratories, setup and maintenance of quality management systems, gap analyses, automation concepts and process optimisation.
International collaboration and market launch
Support for the global launch of IVD products with experience in EU, US and Asian markets. Building and facilitating cooperation with reference laboratories, commercial partners and academic groups, including in matrix structures across time zones and working cultures.
Engagement
Three ways to work together
Consulting is delivered mostly remotely. On-site visits at manufacturers, laboratories and partners are possible by arrangement.
A
Continuous support
A fixed weekly capacity from 10 hours over several months. Suited to programmes that need scientific and regulatory expertise on an ongoing basis without creating a full-time position.
B
Project work with a defined deliverable
Bounded tasks with a clear output: validation plan, gap analysis, Performance Evaluation Report, CDx strategy paper or study protocol.
C
Second opinion
Independent expert assessment of an existing dossier, method or strategy. Short engagement, written opinion, no long-term commitment.