Regulatory Intelligence
See the shift before it reaches your program.
Guidances, rules, and precedents move constantly across every market you operate in. We watch all of it, filter it to what affects you, and tell you what to do about it. A change in Washington or Brussels never becomes a surprise in your program.
Signal, Not Noise
A database tells you what changed. We tell you what it means for your program, and what to do next.
The market is full of feeds, alerts, and databases. They generate volume; what they rarely give you is judgment. Whether a new draft guidance reshapes your filing strategy. Whether a competitor’s Complete Response Letter signals a shifting evidence bar. Whether a change is worth acting on at all. That interpretation is the work, and it is what we do.
Capabilities
Four disciplines, one intelligence function.
We operate as an embedded regulatory intelligence team, covering the full arc from raw signal to strategic decision.
Global Monitoring & Horizon Scanning
Continuous surveillance of agencies, guidances, rulemaking, and legislation across every market that touches your portfolio, so nothing relevant slips past.
Impact Assessment
For every change that matters, a clear read on what it means for your programs: filing strategy, timelines, evidence, and risk. A decision, not a headline.
Competitive & Landscape Intelligence
Precedent analysis across approvals, labels, Advisory Committee outcomes, and Complete Response Letters, so you benchmark against what the agency has actually done.
On-Demand Research
Fast, senior-led answers to the questions that stall a program, such as whether the FDA has accepted an endpoint or how EMA has handled a modality. Answered with evidence.
What We Monitor
Breadth that matches your footprint.
Regulatory risk does not respect borders. We track the sources that shape your program across the world’s major markets, in the formats they are published in.
Health Authorities
- FDA
- EMA
- MHRA
- PMDA
- Health Canada
- TGA & NMPA
Guidance & Rulemaking
- Draft & final guidances
- Federal Register notices
- EU regulations & MDCG
- ICH & ISO updates
- Reflection papers
- Q&A and workshops
Approvals & Actions
- New approvals & labels
- Advisory Committee outcomes
- Complete Response Letters
- Warning letters & 483s
- Safety actions & recalls
- Designation grants
Competitive Signals
- Competitor filings
- Precedent decisions
- Pipeline & label changes
- Policy & legislative shifts
- Litigation of note
- Scientific advice trends
How It Works
From signal to strategy, on a rhythm you can rely on.
Monitor
We continuously scan authorities, publications, and databases across your markets.
Filter
We cut the noise to the changes that touch your programs, portfolio, and pipeline.
Assess
Senior analysts judge the impact and translate it into implications and options.
Advise
You receive briefings, alerts, and recommendations, plus a person to think it through with.
What You Receive
Intelligence, shaped to how you work.
No two clients receive the same feed. We tailor cadence, scope, and format to your portfolio and the decisions in front of you.
Tailored Alerts
Real-time notifications on the changes that affect you, filtered to your programs and free of noise.
Monthly Intelligence Briefings
A curated read on the regulatory landscape for your portfolio, covering what changed and why it matters.
Impact Assessments
Deep-dive analysis on a single change, its consequences for your filings, and the options in front of you.
Competitive Landscape Reports
Precedent and benchmarking on approvals, labels, and agency decisions across your therapeutic space.
Custom Research Memos
Senior-led answers to specific regulatory questions, with sourced evidence and a clear recommendation.
Standing Advisory
A named senior analyst who knows your portfolio and is on call for the fast, high-stakes question.
Work With Us
Stop reacting to regulatory change.
Tell us the markets and programs you need to watch. We’ll build an intelligence function around them and have a senior lead in touch within one business day.
Start the Conversation