Advisory
Advisory
Regulatory Strategy for Global Life Sciences
Regulatory Strategy for Global Life Sciences
Global Reach. Regulatory Precision. Submission-Ready
Global Reach. Regulatory Precision. Submission-Ready
At LucidBio Intelligence we help global life science companies navigate complex regulatory landscapes with clarity and confidence. From strategic planning to full submission authorship, we partner with you to deliver high-quality, regulator-ready outcomes across regions.
At LucidBio Intelligence we help global life science companies navigate complex regulatory landscapes with clarity and confidence. From strategic planning to full submission authorship, we partner with you to deliver high-quality, regulator-ready outcomes across regions.
Advisory
Regulatory Strategy for Global Life Sciences
Global Reach. Regulatory Precision. Submission-Ready
At LucidBio Intelligence we help global life science companies navigate complex regulatory landscapes with clarity and confidence. From strategic planning to full submission authorship, we partner with you to deliver high-quality, regulator-ready outcomes across regions.
Our Services
With Over 3 Decades of Regulatory Filing Expertise
End-to-end global planning
Pathway assessments across multiple authorities
Market entry timelines and regulatory forecasting
Gap analysis and compliance readiness
Our Services
With Over 3 Decades of Regulatory Filing Expertise
End-to-end global planning
Pathway assessments across multiple authorities
Market entry timelines and regulatory forecasting
Gap analysis and compliance readiness
Our Services
With Over 3 Decades of Regulatory Filing Expertise
End-to-end global planning
Pathway assessments across multiple authorities
Market entry timelines and regulatory forecasting
Gap analysis and compliance readiness
Integrated Regulatory Submissions
We offer comprehensive regulatory submission support, combining strategic planning with high-quality dossier development. From global roadmap design to eCTD-compliant authoring, our services are tailored to meet the expectations of agencies worldwide. Whether you're preparing for IND, CTA, NDA, or MAA filings, we ensure your submission is accurate, aligned, and delivered on time. Deliverables include: End-to-end submission roadmaps Risk mitigation and regulatory insights CTD and eCTD-ready documents Expert M2/M3 scientific summaries AI-focused submission strategy for digital health and SaMD
Integrated Regulatory Submissions
We offer comprehensive regulatory submission support, combining strategic planning with high-quality dossier development. From global roadmap design to eCTD-compliant authoring, our services are tailored to meet the expectations of agencies worldwide. Whether you're preparing for IND, CTA, NDA, or MAA filings, we ensure your submission is accurate, aligned, and delivered on time. Deliverables include: End-to-end submission roadmaps Risk mitigation and regulatory insights CTD and eCTD-ready documents Expert M2/M3 scientific summaries AI-focused submission strategy for digital health and SaMD
Integrated Regulatory Submissions
We offer comprehensive regulatory submission support, combining strategic planning with high-quality dossier development. From global roadmap design to eCTD-compliant authoring, our services are tailored to meet the expectations of agencies worldwide. Whether you're preparing for IND, CTA, NDA, or MAA filings, we ensure your submission is accurate, aligned, and delivered on time. Deliverables include: End-to-end submission roadmaps Risk mitigation and regulatory insights CTD and eCTD-ready documents Expert M2/M3 scientific summaries AI-focused submission strategy for digital health and SaMD
Full submission roadmaps IND, NDA, CTA, MAA, etc.
End to End Strategy
Full submission roadmaps IND, NDA, CTA, MAA, etc.
End to End Strategy
AI submissions and digital health compliance
AI-Driven Submissions
AI submissions and digital health compliance
AI-Driven Submissions
Regulatory Insight
Shift filing strategy in response to AI-readiness trends (FDA, EU AI Act, MHRA, PMDA).
Regulatory Insight
Shift filing strategy in response to AI-readiness trends (FDA, EU AI Act, MHRA, PMDA).
Risk mitigation and decision-ready insights
Proactive Risk Management
Risk mitigation and decision-ready insights
Proactive Risk Management
eCTD-compliant writing
Regulatory-Ready Documents
eCTD-compliant writing
Regulatory-Ready Documents
Clinical and nonclinical summary modules (M2/M3)
Expert Scientific Summaries
Clinical and nonclinical summary modules (M2/M3)
Expert Scientific Summaries
Expertise
Not a Dashboard. A Playbook
Expertise
Not a Dashboard. A Playbook
Expertise
Not a Dashboard. A Playbook
Forecasts That Actually Update
Forecasts That Actually Update
Don’t build on outdated assumptions. Our CI models update with every regulatory signal and operational shift — so your roadmap stays live.
AI In Regulatory Affairs
AI in Regulatory Affairs Intelligent Automation, Smarter Strategy
We apply AI to streamline regulatory workflows, enhance submission accuracy, and reduce cycle times. Our tools support document analysis, risk flagging, and real-time insight generation—helping teams move from manual bottlenecks to intelligent action.
Competitive Intelligence Solutions
We streamline our products to provide curated intelligence for each subscription tier
Customizable Dashboards
Our CI tiers provide clients the ability to choose the best personalized dashboard subscription.
AI In Regulatory Affairs
AI in Regulatory Affairs Intelligent Automation, Smarter Strategy
We apply AI to streamline regulatory workflows, enhance submission accuracy, and reduce cycle times. Our tools support document analysis, risk flagging, and real-time insight generation—helping teams move from manual bottlenecks to intelligent action.
Competitive Intelligence Solutions
We streamline our products to provide curated intelligence for each subscription tier
Customizable Dashboards
Our CI tiers provide clients the ability to choose the best personalized dashboard subscription.
AI In Regulatory Affairs
AI in Regulatory Affairs Intelligent Automation, Smarter Strategy
We apply AI to streamline regulatory workflows, enhance submission accuracy, and reduce cycle times. Our tools support document analysis, risk flagging, and real-time insight generation—helping teams move from manual bottlenecks to intelligent action.
Competitive Intelligence Solutions
We streamline our products to provide curated intelligence for each subscription tier
Customizable Dashboards
Our CI tiers provide clients the ability to choose the best personalized dashboard subscription.
FAQs
Frequently Asked Questions
FAQs
Frequently Asked Questions
FAQs
Frequently Asked Questions
How is this different from enterprise platforms like AlphaSense or Cortellis?
Enterprise platforms provide self-service database access—you search and analyze yourself. We provide analyst-driven strategic intelligence—human experts who deliver insights and recommendations specific to your needs. Think of us as your fractional CI team, not a software subscription.
What’s shifting in the landscape — and why should I care now?
Because timing matters. We track not just competitor actions, but the strategic meaning behind them.
How do you gather competitive intelligence?
We analyze publicly available sources including ClinicalTrials.gov, regulatory databases, scientific publications, company press releases, investor presentations, and conference proceedings. All work is conducted ethically and legally. We never use corporate espionage or questionable methods.
Can I use these reports in investor materials?
Yes. The reports are yours to use as you see fit—in pitch decks, board presentations, or strategic planning documents. We can also format deliverables to match your investor deck style upon request.
What if my competitors are private companies with limited information?
We specialize in piecing together intelligence from fragmentary sources. Even private biotechs leave digital footprints through trial registries, publications, patents, job postings, and conference presentations. This is where analyst expertise matters—connecting the dots that platforms miss.
How long does it take to get a competitive intelligence report?
One-time reports: 2 weeks from kickoff to final delivery, including a 60-minute strategy debrief call. Free competitive briefs: 3-5 business days. Monthly subscriptions: Initial setup takes 1-2 weeks, then you receive ongoing briefings on your chosen schedule (weekly, bi-weekly, or monthly). We prioritize speed without sacrificing quality—perfect for biotech teams working against tight timelines.
What if I'm not sure which service I need?
Start with our free 1-page competitive brief. This gives you a taste of our analysis style and helps us understand your specific needs. Based on that initial brief, we can recommend whether a one-time report, monthly subscription, or custom project makes the most sense for your situation. No pressure, no obligation—we'd rather recommend the right fit than oversell.
Do you work with companies outside the UK?
Yes, we have operations in UK & US. We work with biotech companies globally—UK, EU, US, Canada, and beyond. Our intelligence coverage is international (we track FDA, EMA, PMDA, and other regulatory bodies), and we deliver reports remotely via video calls and digital documents. Time zone differences are never an issue—we schedule debriefs at times that work for your team.
How is this different from enterprise platforms like AlphaSense or Cortellis?
Enterprise platforms provide self-service database access—you search and analyze yourself. We provide analyst-driven strategic intelligence—human experts who deliver insights and recommendations specific to your needs. Think of us as your fractional CI team, not a software subscription.
What’s shifting in the landscape — and why should I care now?
Because timing matters. We track not just competitor actions, but the strategic meaning behind them.
How do you gather competitive intelligence?
We analyze publicly available sources including ClinicalTrials.gov, regulatory databases, scientific publications, company press releases, investor presentations, and conference proceedings. All work is conducted ethically and legally. We never use corporate espionage or questionable methods.
Can I use these reports in investor materials?
Yes. The reports are yours to use as you see fit—in pitch decks, board presentations, or strategic planning documents. We can also format deliverables to match your investor deck style upon request.
What if my competitors are private companies with limited information?
We specialize in piecing together intelligence from fragmentary sources. Even private biotechs leave digital footprints through trial registries, publications, patents, job postings, and conference presentations. This is where analyst expertise matters—connecting the dots that platforms miss.
How long does it take to get a competitive intelligence report?
One-time reports: 2 weeks from kickoff to final delivery, including a 60-minute strategy debrief call. Free competitive briefs: 3-5 business days. Monthly subscriptions: Initial setup takes 1-2 weeks, then you receive ongoing briefings on your chosen schedule (weekly, bi-weekly, or monthly). We prioritize speed without sacrificing quality—perfect for biotech teams working against tight timelines.
What if I'm not sure which service I need?
Start with our free 1-page competitive brief. This gives you a taste of our analysis style and helps us understand your specific needs. Based on that initial brief, we can recommend whether a one-time report, monthly subscription, or custom project makes the most sense for your situation. No pressure, no obligation—we'd rather recommend the right fit than oversell.
Do you work with companies outside the UK?
Yes, we have operations in UK & US. We work with biotech companies globally—UK, EU, US, Canada, and beyond. Our intelligence coverage is international (we track FDA, EMA, PMDA, and other regulatory bodies), and we deliver reports remotely via video calls and digital documents. Time zone differences are never an issue—we schedule debriefs at times that work for your team.
How is this different from enterprise platforms like AlphaSense or Cortellis?
Enterprise platforms provide self-service database access—you search and analyze yourself. We provide analyst-driven strategic intelligence—human experts who deliver insights and recommendations specific to your needs. Think of us as your fractional CI team, not a software subscription.
What’s shifting in the landscape — and why should I care now?
Because timing matters. We track not just competitor actions, but the strategic meaning behind them.
How do you gather competitive intelligence?
We analyze publicly available sources including ClinicalTrials.gov, regulatory databases, scientific publications, company press releases, investor presentations, and conference proceedings. All work is conducted ethically and legally. We never use corporate espionage or questionable methods.
Can I use these reports in investor materials?
Yes. The reports are yours to use as you see fit—in pitch decks, board presentations, or strategic planning documents. We can also format deliverables to match your investor deck style upon request.
What if my competitors are private companies with limited information?
We specialize in piecing together intelligence from fragmentary sources. Even private biotechs leave digital footprints through trial registries, publications, patents, job postings, and conference presentations. This is where analyst expertise matters—connecting the dots that platforms miss.
How long does it take to get a competitive intelligence report?
One-time reports: 2 weeks from kickoff to final delivery, including a 60-minute strategy debrief call. Free competitive briefs: 3-5 business days. Monthly subscriptions: Initial setup takes 1-2 weeks, then you receive ongoing briefings on your chosen schedule (weekly, bi-weekly, or monthly). We prioritize speed without sacrificing quality—perfect for biotech teams working against tight timelines.
What if I'm not sure which service I need?
Start with our free 1-page competitive brief. This gives you a taste of our analysis style and helps us understand your specific needs. Based on that initial brief, we can recommend whether a one-time report, monthly subscription, or custom project makes the most sense for your situation. No pressure, no obligation—we'd rather recommend the right fit than oversell.
Do you work with companies outside the UK?
Yes, we have operations in UK & US. We work with biotech companies globally—UK, EU, US, Canada, and beyond. Our intelligence coverage is international (we track FDA, EMA, PMDA, and other regulatory bodies), and we deliver reports remotely via video calls and digital documents. Time zone differences are never an issue—we schedule debriefs at times that work for your team.
Get Started
Ready To Gain An Edge On A Volatile Life Science Landscape
AI in Safety Compliance Competitive Intelligence Report
Get Started
Ready To Gain An Edge On A Volatile Life Science Landscape
AI in Safety Compliance Competitive Intelligence Report
Get Started
Ready To Gain An Edge On A Volatile Life Science Landscape
AI in Safety Compliance Competitive Intelligence Report