Regulatory intelligence for a small biotech or a lean brand team is usually a shared inbox, a consultant newsletter, and someone who “keeps an eye on FDA.gov.” That works until it does not: a guidance drop, a safety communication, an approval in your class that changes the conversation overnight.
RegulatoryAlerts is regulatory alert monitoring software: continuous coverage of FDA, EMA, and other agencies, with therapeutic filtering and executive summaries so you are not reading every raw feed.
What continuous monitoring is for
The job is not “more alerts.” The job is not missing the ones that change your plan.
- Approvals and labelling changes in your therapeutic area
- Draft and final guidance that affects how you talk, trial, or file
- Safety communications that will hit medical information and field teams
- Agency activity outside the US and UK that your current vendor treats as optional
Filtering by therapy area is the difference between a firehose and a briefing. Summaries are there so a regulatory or medical lead can decide in minutes whether something needs a deeper read.
Who it is for
- Regulatory and medical affairs in small and mid-size biotech
- Brand teams who need agency context without a dedicated intelligence function
- Consultants who currently assemble this by hand
If promotional claims and evidence trails are the problem, that is PromoPack. If you want a human to help interpret what a change means for France or a commercial plan, that is Elliogen advisory.