The Importance of Regulatory Correspondence Tracking: Best Practices for Pharma Teams

In the highly regulated world of pharmaceuticals, keeping a meticulous record of

regulatory correspondence isn’t just a good idea—it’s essential. Misplaced or poorly

tracked communications can lead to compliance issues, missed deadlines, or confusion

during audits. A strong regulatory correspondence tracking system is your team’s best defense against these challenges.

Here are the best practices for maintaining a reliable and organized correspondence

tracking system:

1. Consistent File Naming Conventions

Standardized file names make locating specific documents much easier. A simple yet

effective approach is to begin filenames with the numerical date in the format YYYY-

MM-DD, followed by a brief description. For example, 2024-12-02-fda-meeting-

request.pdf. This method ensures files are easily sortable by date and content.

2. Keep Filenames Manageable

While clarity is key, brevity is equally important. Filenames should be under 100

characters to avoid exceeding the 260-character limit for file paths in some operating

systems. Keep descriptions concise, and ensure any abbreviations are consistent and

universally understood by the team.

3. Use Standardized Abbreviations

Develop and maintain a list of standardized abbreviations for commonly used terms.

This practice minimizes confusion and ensures consistency, especially in collaborative

environments.

4. Opt for PDFs

PDFs are widely considered the gold standard for regulatory correspondence. They are

easily readable, have better preservation of formatting, and are compatible with

submission platforms. Avoid storing files in proprietary formats like .msg or .docx to

prevent accessibility issues.

5. Provide Clear Instructions for Brief Descriptions

Make it easy for your team to draft accurate, concise brief descriptions for filenames.

Clear guidelines on what to include—such as the nature of the correspondence and the

recipient—will save time and reduce errors.

6. Centralized Tracking Mechanism

Whether you invest in a Regulatory Information Management (RIM) solution like Veeva

or use a simpler tool such as Excel, a centralized system is crucial. This tracker should

log essential details like dates, subjects, related submissions, and key actions. Ensure

it’s regularly updated and accessible to relevant stakeholders.

Why Robust Regulatory Correspondence Tracking Matters

Beyond compliance, a well-maintained regulatory correspondence tracker enables

teams to work more efficiently, reduces duplication of effort, and facilitates smoother

transitions during personnel changes. It’s also invaluable during audits, when timely

access to documentation can make all the difference.

Take the Next Step

Ready to enhance your regulatory correspondence practices? Sign up for our

newsletter today and receive a free correspondence tracker template. This tool is

designed with industry best practices in mind to help your team stay organized and

compliant.

If your regulatory correspondence is currently a bit of a mess, we can help with that too!

The Sugar Water Operations Team can sort through your correspondence, rename

each file with standard conventions, and make sure each and every piece is tracked

and easily found. Contact us today to discuss how we can help.