Regulatory Solutions
by Sincerely PharmD
ADVERSE EVENT READINESS
Your adverse event process
may have gaps you cannot see.
Is your company compliant?
Most dietary supplement brands have some version of an adverse event process. This typically involves a shared inbox, a spreadsheet, or a form, but many brands are missing the confidence that their processes would be defendable under an FDA inspection or a retailer audit.
Without clear internal regulatory frameworks, a missing record can turn into an unreported serious AE. A label claim can create a documentation obligation that went unnoticed. These are the issues that generate warning letters.
This free 10-question assessment takes 10 minutes and tells you where you stand.
WHAT YOU WILL LEARN
You will gain insight into your AE readiness.
Answer 10 questions about your current processes. You will receive an immediate, scorecard result that identifies which areas are solid and where you can focus your regulatory strategy.
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If your intake process truly compliant (and is it working effectively), whether it follows FDA regulations and requirements
How serious assessments are impacting your business (and what you might be doing wrong)
Where your company stands in terms of regulatory risk
ABOUT SINCERELY PHARMD
Sincerely PharmD works with dietary supplement brands, contract manufacturers, and e-commerce sellers to help them understand and manage their regulatory obligations. The goal is straightforward: keep your products on the market and out of warning letters by building the internal competency to make sound compliance decisions.
Developed by a healthcare professional with expertise drawn from tens of thousands of adverse event reviews across dietary supplements, cosmetics, and related product categories, and direct regulatory support working with hundreds of companies.
10,000+
Adverse events reviewed
100+
Companies supported
PharmD
Clinical Expertise
WHAT REGULATORY TRENDS ARE TELLING US
FDA's adverse event reporting requirements for dietary supplements under 21 CFR Part 111 and the FD&C Act apply regardless of company size.
Inadequate recordkeeping is one of the most cited 483 observations in supplement facility inspections.
Brands marketing dietary supplement products are expected to have processes in place to identify and evaluate consumer-reported events, including those that meet the statutory definition of a serious adverse event.
Major retailers and third-party marketplaces increasingly require demonstrated compliance as a condition of listing.
Find out where your AE process stands.
Free | 10 Questions | Personalized Results