Regulatory Intelligence Services

We provide a service that rapidly gathers, compares, and organizes primary source information, transforming it into a format that is ready for your decision-making.

We offer perfectly scoped, decision-focused regulatory insights that you can't get from existing information providers or consulting firms, delivered through two core plans: Standard Reports and Custom Reports.

【Are You Facing These Intelligence Dilemmas?】

The 'Information Overload' Trap
You have a contract for an expensive database, but it's full of noise, and it still takes an immense amount of time to find and understand the information that is truly important.

The 'High-Cost Project' Barrier
You just want to confirm a specific point, but requesting it from a consulting firm turns into a large-scale project where the budget and timeline don't align with your needs.

The Risk of 'Key Person Dependency' and Oversights
Your process relies on the efforts and experience of a specific team member. If that person is busy, on leave, or leaves the company, the quality of your intelligence gathering cannot be maintained, and the risk of missing critical changes increases.

【The New Alternative We Provide】

We solve these dilemmas and elevate your regulatory intelligence process to the next level.

You no longer need to drown in a flood of information.
We deliver only the "filtered signals," with the noise thoroughly removed by our curators.

You no longer need to give up due to cost or time.
We offer "agile intelligence reports" that you can purchase by the theme, delivering outstanding cost-performance.

You no longer need to rely on individual effort.
We provide a "systematic process" that eliminates key person dependency and enables anyone to obtain high-quality information.

Our Services

  1. Standard Reports（Regulatory Signal Briefs）

An 8-12 page report that organizes a specific regulatory theme. We regularly cover topics that require annual or semi-annual updates. You can purchase only the themes you need, when you need them.

  • Sectors: Pharma, MedTech, SaMD, IVD, ATMP, etc.
  • Regions: US, EU, Japan, Asia
  • Languages: Available in English or Japanese
  • Price
  • Price per report: $1,500 USD
  • Special Launch Price: $1,000 USD (Limited Time Offer)

Report Structure

  • Executive Summary: Key takeaways from the report.
  • 3-5 Signal Cards*
    • What changed? (Key points of the regulatory change)
    • Key Data & Comparison (Consolidated differences & country-by-country comparisons)
    • Source Links (Links to the primary source information)

*The Signal Card is our proprietary format that organizes the most important facts about a single regulatory theme onto one page. Because the key points, comparative data, and source links are always presented in the same structure, anyone can instantly grasp the situation and use it directly for team discussions and reports.

Example Report Themes:

Clinical × Pharma

  • Impact of the ICH E6(R3) Revision
  • Comparison of DCT Guidance (FDA/EMA)
  • Pediatric Study Obligations

Approval × MedTech

  • EU MDR Review Delays
  • Updates to the FDA Breakthrough Devices Program
  • China NMPA's Accelerated Approval Programs

HTA × SaMD

  • Comparison of Evaluation Criteria: Japan's DigiHTA vs. Germany's DiGA
  • Trends in Digital Therapeutics Reimbursement by CMS in the US
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  1. Custom Reports (Custom Regulatory Dossier)

We conduct bespoke research and analysis tailored to your specific products or challenges. Our custom reports bridge the gap between what internal teams cannot cover and what would otherwise require costly consulting engagements.

Example Custom Projects:

  • Impact of US DCT guidance revisions on clinical trials in Japan.
  • Comparison of approval pathways and accelerated programs for ADCs in the US, EU, and Japan.
  • Trial design requirements for Companion Diagnostics (FDA, EMA, PMDA).
  • HTA evaluation of Digital Therapeutics (DTx) in Japan, Germany, and the US.
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