FOR REGULATORY AFFAIRS

You Were Hired to Be a Regulatory Expert. Not a Data Assembler.

Smarteeva automates the data-intensive side of regulatory reporting, generating MedWatch drafts, assembling PSURs, detecting adverse events, and validating submission completeness, so your expertise goes to the work that actually requires it.

The problem

H o w m u c h o f y o u r d a y i s a c t u a l l y s p e n t o n t h a t w o r k ? T o o m u c h o f i t g o e s t o t a s k s t h a t d o n ' t r e q u i r e y o u r e x p e r t i s e.

Hours lost before a word is written \nPulling complaint data from the quality system, transferring it into regulatory forms, and tracking down missing information from other departments.

Reports built by hand, error by error

Manually compiling PMS reports from multiple data sources, formatting submissions to match agency expectations, checking for consistency errors that shouldn't exist.

Validating what should be automatic \nChecking completeness, cross-referencing fields, confirming nothing was missed before filing. Work that software should handle before it reaches your desk.

Never Miss a Reportable Event

Smarteeva's NLP scans every complaint narrative for indicators of adverse events, injuries, malfunctions, and safety signals.

Flagged events arrive on your desk with the specific language that triggered the detection, the event type classification, and the applicable regulatory framework. You evaluate with full context, not with a vague referral that says "please review."You stop worrying about what your team might have missed in the pile. AI reviewed the pile. Every complaint. Every word.

Submissions Generated in Minutes

MedWatch reports, MDR forms, EU Vigilance reports are auto-generated by mapping complaint and assessment data to regulatory fields. You review a complete draft. You refine the narrative. You approve with an e-signature. The data assembly that used to take hours is done before your first cup of coffee.

PMS Reports in 8 Minutes

EU PSUR, UK PSUR, PMSR, PMPF-ER, HCSR - all produced automatically from your quality data. Statistical summaries, trend analyses, and regulatory sections are assembled and formatted. You review, add expert commentary, and submit. What used to consume weeks of your time is now a review exercise.

Global Framework Coverage

FDA, EU MDR, UK MDR, PMDA, TGA - Smarteeva supports the regulatory reporting requirements you face across every market you operate in. One platform generates submissions for multiple jurisdictions, mapping the same underlying complaint data to each framework's specific requirements.

Pre-Submission Validation

Before any report leaves your desk, Smarteeva validates completeness and consistency. Missing required fields, data conflicts, and formatting issues - all flagged before submission. You file clean reports the first time. FDA follow-up requests for missing data have become rare instead of routine.

From Weeks to Minutes.

For a company filing 50+ MedWatch reports per year and producing PSURs for multiple product families, the annualized time savings often exceeds thousands of hours, freeing your regulatory team to focus on submission quality, agency interactions, and strategic regulatory planning.

Task

  • MedWatch report preparation
  • PSUR compilation
  • Adverse event screening
  • Data gathering for submissions
  • Pre-submission error checking

Before Smarteeva

  • 2-4 hours per report
  • 100+ hours per report
  • Manual review of every complaint narrative
  • Hours per submission, multiple source systems
  • Manual, inconsistent

With Smarteeva

  • Minutes (AI-generated, review only)
  • 8 minutes (AI-generated, review only)
  • AI reviews every narrative; you review AI flags
  • Auto-pulled from integrated quality data
  • Automated validation on every submission

See Automated Regulatory Reporting

Whether you're a 10-person startup or a global enterprise, this is the same platform. No tiers. No feature gates.