Tailored consulting for every phase of IVD product development
Assay design and development, method validation, analytical performance evaluation, and scientific expertise for LC-MS/MS-based clinical diagnostics. Consulting on Therapeutic Drug Monitoring (TDM), drug analytics, and toxicological topics.
Guidance through the regulatory process under EU IVDR and FDA guidelines. Support with technical documentation, conformity assessments, and approval applications. Expertise in ISO 13485, 15189, and 17025.
Planning and management of clinical performance studies, collaboration with Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs), and bridging communication between Medical Affairs and clinical partners.
Strategic consulting on the significance of CDx in personalized medicine. Improving the analytical performance of companion diagnostics within biosimilar development programs.
Consulting on the strategic direction of clinical laboratories, implementation of automation solutions, quality management systems, and optimization of laboratory processes for greater efficiency.
Support with the global launch of IVD products with experience across EU, US, and international markets. Building relationships with reference laboratories and industry partners worldwide.