Bridging the gap between local laboratory operations and FDA/EMA regulatory expectations.
Request a Global Consultation →Optimizing IHC for IND-enabling studies with regulatory alignment and risk mitigation strategies that protect your investment.
Managing WSI data integrity across borders with secure workflows, metadata standards, and cross-regional compliance frameworks.
Bespoke SOP development for international scaling with audit-ready documentation that meets FDA, EMA, and regional requirements.
Real-world examples of our international pathology advisory work across diverse regions and applications.
Optimized IHC protocols for a Korean-based oncology program moving to US Phase I.
Designed image management governance for a Middle Eastern biobanking initiative.
Troubleshot fixation-related assay failures for an APAC-based diagnostic developer.
A streamlined 1-2-3 process designed for global collaboration with dedicated support windows for APAC/EMEA time zones.
Encrypted uploads and secure file sharing protocols ensure your sensitive pathology data remains protected throughout the transfer process.
Senior pathology scientists conduct comprehensive analysis and provide strategic guidance aligned with FDA/EMA regulatory expectations.
Actionable reports, protocols, and recommendations delivered with implementation support tailored to your regional requirements.
✓ Dedicated support windows for APAC/EMEA time zones
We maintain strict CDA/NDA adherence and implement 'Stealth' project management protocols to ensure your intellectual property and sensitive data remain protected throughout our engagement.
Ideal for specific deliverables like SOP development, gap analyses, or protocol optimization.
We align our consulting with your drug development milestones (e.g., Pre-IND, Phase I readout).
Long-term, on-call pathology judgment for teams requiring consistent oversight across multiple programs.
Consulting engagements are tailored to the complexity and regulatory stage of your program. Contact us for a bespoke proposal.
Tell us about your international pathology needs and we'll connect you with our global advisory team.