—How We Help
Six ways we support diagnostic strategy
Therapeutic Diagnostic Strategy
Supporting diagnostic decisions from biomarker selection through patient access, aligned with IVDR and FDA companion diagnostic requirements from the earliest stages of development.
Strategic Advisory
Supporting executive teams, investors and development partners as they make the critical decisions that shape diagnostic programmes, from portfolio strategy and technology evaluation to due diligence and global market planning.
Global Regulatory Pathways
Building evidence and regulatory strategies across international markets, spanning IVDR, US FDA pathways, and UKCA requirements.
Clinical & Companion Diagnostic Development
Aligning diagnostics with therapeutic development programmes, from Annex XIV clinical performance studies through companion diagnostic co-development.
Laboratory & Operational Readiness
Helping laboratories translate strategy into reliable implementation, in line with ISO 13485, ISO 15189, ISO 20916 and CAP/CLIA requirements.
Diagnostic Partner Assessments
Independent assessments of diagnostic developers, laboratories and strategic partners, identifying programme strengths, risks and development readiness before critical investment or partnership decisions are made.
Global Diagnostic Perspective
Diagnostic development is global. Regulatory pathways are not. Synidian supports diagnostic strategy across international markets, helping you consider regional requirements within the context of a global development programme.
