Regulatory intelligence

What changed, and what it means.

Guidance and regulations change frequently, without notice. We track what matters to clinical studies and explain what each change means for your procedures.

The Gray Letter · monthly

Stay current without reading every guidance yourself.

Each issue covers the changes that matter to your studies, what they mean for your SOPs, and the dates to plan around. Every subscription includes the full library of back issues.

Individual
$180 a year
  • A new issue every month
  • The full back-issue library
  • 1 reader
Subscribe for $180 a year
Team
$750 a year
  • A new issue every month
  • The full back-issue library
  • Up to 5 named readers
Subscribe for $750 a year

Included for every team that subscribes to the Template Portal. Subscribers sign in to the library with their email.

Services

When a change affects your study.

Scoped to your portfolio after a short call.

Change tracking

A watch on the regulators and standards your studies depend on, with a log of what changed and when.

Book a scoping call

Impact assessment

One change, such as a new FDA guidance, mapped against your SOPs and plans, with the updates it calls for.

Book a scoping call

Regulatory briefings

A walkthrough of a change for your team, focused on how the changing landscape affects you.

Book a scoping call
Standards library

The requirements, at the source.

A few of the 21 official sources in our standards library. Register free for the full list and our free checklists and guides.

ICH
ICH E6(R3)
Good Clinical Practice, consolidated guideline
US
21 CFR Part 11
Electronic records; electronic signatures
EU
Regulation (EU) No 536/2014
Clinical trials on medicinal products
ISO
ISO 14155:2020
Clinical investigation of medical devices for human subjects: good clinical practice
Next step

Talk through a change.

A 30-minute call to understand your study, agree the scope and set a fixed estimate.

Book a scoping call
Free resources