Biotech, CROs, and medical device companies face multi-agency compliance across three major regulatory ecosystems. VelorQ handles the intelligence layer so your science can move at the pace it deserves.
Different agencies, overlapping requirements, evolving guidance documents — keeping pace with global regulatory intelligence is a full-time job that shouldn't distract from core science.
FDA, EMA, and CDSCO each publish hundreds of guidance updates, consultation documents, and regulatory decisions annually. Tracking what matters for your specific molecule, device, or therapeutic area requires dedicated resources most organisations don't have.
Clinical, safety, and scientific literature grows by thousands of papers each month. Systematic literature review for pharmacovigilance, clinical evidence, or competitive intelligence is time-consuming and falls behind when teams are focused on submissions.
Designing clinical trial protocols that anticipate regulatory requirements across target markets requires deep, current knowledge of agency preferences, precedent decisions, and evolving scientific standards — knowledge that's locked in documents and prior submission history.
Four AI agents and tools covering regulatory intelligence, evidence discovery, strategic decisions, and analytics — built for biotech, CROs, and medical device companies.
Monitors FDA, EMA, and CDSCO for guidance updates, consultation documents, and regulatory decisions relevant to your portfolio. Extracts actionable requirements and maps them to your development programme.
Learn more →AI-powered literature surveillance across PubMed, ClinicalTrials.gov, and regulatory databases. Surfaces relevant clinical evidence, competitive intelligence, and safety signals within your defined therapeutic scope.
Learn more →Decision intelligence for regulatory strategy. Analyses precedent agency decisions, comparable product approval pathways, and scientific advice outcomes to inform regulatory and development strategy with evidence.
Learn more →Tracks submission timelines, approval rates, regulatory query patterns, and portfolio compliance KPIs. Generates agency-specific performance dashboards and regulatory milestone reports for leadership.
Learn more →These are the intelligence and regulatory workflows activated in the first 30 days by our life sciences customers.
A mid-size biotech company with programmes targeting both US and EU markets uses RegIntel to monitor FDA and EMA simultaneously. When a new guidance document or CHMP opinion is published in their therapeutic area, the team receives a curated brief — not a raw PDF — with applicability and recommended actions within 24 hours.
A CRO managing pharmacovigilance for 12 molecules uses Discover to run automated literature surveillance across PubMed and WHO databases each week. The system extracts safety-relevant case reports and signals, categorises by seriousness, and delivers a pre-screened list for medical officer review — replacing a week of manual work.
Before filing for a new indication, a specialty pharma company uses Decide to analyse FDA precedent decisions for comparable molecules in the same class — extracting what data packages were accepted, what questions were raised, and what special designations were granted. The output directly shapes their pre-IND meeting strategy.
Regulatory agencies monitored simultaneously — FDA, EMA, CDSCO
Turnaround from guidance publication to actionable brief
Reduction in manual literature surveillance time for PV teams
Time to first live regulatory intelligence dashboard from onboarding
Book a 30-minute demo specific to your context — biotech, CRO, or medical devices. We'll map RegIntel and Discover to your actual regulatory portfolio.