Regulatory

Skills to get you started. Explore skills to boost your productivity.

$45

PSUR4.6(5)

PSUR Safety Report Compiler

Automate PSUR assembly with ICH-compliant safety data synthesis and signal detection

by kurtosis-tech

Adverse Event Assessment & Regulatory Report Generator

$30

Adverse Event3.5(4)

Adverse Event Assessment & Regulatory Report Generator

Classify adverse events and generate FDA/ICH-compliant pharmacovigilance reports

by kurtosis-tech

FDA Submission Strategy & Regulatory Narrative Builder

$35

FDA3.7(3)

FDA Submission Strategy & Regulatory Narrative Builder

Build FDA submissions faster with AI-powered regulatory strategy

by najicham

Pharmacovigilance Signal Detection Assistant

$35

Signal Detection3.8(6)

Pharmacovigilance Signal Detection Assistant

Detect adverse drug signals, assess causality, and prepare regulatory reports

by najicham

$25

EMA/International3.8(5)

EMA Regulatory Dossier Strategist

Build EMA-compliant regulatory dossiers with structured workflows and checkpoints

by najicham

EMA/International Regulatory Submission Compliance Verifier

$30

EMA/International3.7(6)

EMA/International Regulatory Submission Compliance Verifier

Verify regulatory submission readiness and identify CTD compliance gaps before EMA filing

by najicham

Post-Market Safety Intelligence & Regulatory Response

$35

Post-Market4.0(5)

Post-Market Safety Intelligence & Regulatory Response

Monitor safety signals and automate regulatory responses post-launch

by najicham

FDA Submission Strategy & Deficiency Letter Analyzer

$40

FDA3.3(3)

FDA Submission Strategy & Deficiency Letter Analyzer

Navigate FDA pathways and deficiency letters with strategic precision

by najicham

Popular in Regulatory

Pharmacovigilance Specialist

Regulatory Affairs Specialist

Popular sellers

All skills

No skills found

Try adjusting your filters to find what you're looking for.