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Sarah Reyes

Regulatory Affairs Lead @ Fortae

2h ago·Prompt·Life Sciences

FDA Submission Gap Analysis & IND Readiness Checker

Review dossier sections against FDA 21 CFR Part 312 and flag gaps before IND filing. Saves ~4 hrs per submission cycle.

24 89 567 4.8k 234

Marcus Kim

Senior Associate @ Fortae

5h ago·Workflow·Legal

Contract Review Automation — 5-Step Legal Workflow

Extracts key clauses, flags risks, and generates a redline summary. Built for NDA and MSA reviews.

31 56 423 3.6k 156

Anika Tran

Staff Engineer @ Fortae

Yesterday·Skill·Software Eng.

GitHub PR Review Assistant — Code Review Skill

Reviews pull requests for logic errors, style violations, and security issues. Structured feedback in seconds.

47 38 207 5.1k 318

Sarah Reyes

Regulatory Affairs Lead @ Fortae

2h ago·Prompt·Life Sciences·Claude

FDA Submission Gap Analysis & IND Readiness Checker

Analyzes a dossier section against FDA 21 CFR Part 312 and flags gaps before IND filing. Saves ~4 hrs per submission cycle.

You are a senior regulatory affairs specialist. Review the following dossier section and identify any gaps relative to FDA 21 CFR Part 312 requirements. For each gap: cite the specific regulation, describe the issue, and suggest a remediation action. Output as a structured table...

FDARegulatoryIND21 CFR

84 24 12 1.2k

Marcus Kim

Used this for our IND package last week — caught 3 gaps we had missed.

Anika Tran

Does this work for ANDA submissions too or is it IND-specific?

D. Park

Saved to my wallet — planning to adapt for BLA submissions.

Wallet12 saved · 3 published

All SavedMy ArtifactsPromptsWorkflowsSkills

Prompt

FDA Gap Analysis & IND Readiness

You are a senior regulatory affairs specialist. Review the dossier and identify gaps relative to FDA 21 CFR Part 312...

Workflow

Contract Review Automation

Step 1: Extract all defined terms. Step 2: Identify indemnification clauses. Step 3: Flag non-standard provisions...

Skill

GitHub PR Review Assistant

Review this pull request diff for logic errors, security vulnerabilities, and style violations. Return structured JSON...

Prompt

Clinical Trial Eligibility Screener

Given the following patient profile and inclusion/exclusion criteria, determine eligibility and explain reasoning...

Workflow

IP Landscape Mapping Pipeline

Step 1: Search USPTO and EPO for composition of matter patents. Step 2: Extract key claims. Step 3: Build expiry timeline...

Skill

Unit Test Generator for TypeScript

Given the following TypeScript function, generate comprehensive Jest unit tests covering happy path, edge cases, and error states...

Prompt

Drug Pricing Strategy Memo

You are a market access strategist. Draft a pricing rationale memo for a drug targeting a specific payer type...

Workflow

M&A Due Diligence Checklist

Step 1: Review target cap table. Step 2: Analyze trailing 12-month revenue. Step 3: IP ownership audit...

Prompt

Biomarker Discovery Prompt Set

Analyze the gene expression dataset and identify candidate biomarkers associated with the target condition...

Wallet3 published

All SavedMy ArtifactsPromptsWorkflowsSkills

Prompt

FDA Gap Analysis & IND Readiness

You are a senior regulatory affairs specialist. Review the dossier and identify gaps relative to FDA 21 CFR Part 312...

Workflow

IND Filing 5-Step Pipeline

Step 1: Pre-IND meeting prep. Step 2: CMC documentation review. Step 3: Nonclinical gap analysis. Step 4: Clinical protocol...

Prompt

Drug Pricing Strategy Memo

You are a market access strategist. Draft a pricing rationale memo for a drug targeting a specific payer type...

Sarah Reyes

@sarah.reyes

Regulatory Affairs Lead

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Regulatory affairs specialist focused on IND/NDA submissions and FDA strategy. Building AI workflows to make drug development faster and smarter.

FDARegulatoryINDLife SciencesClaude

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Prompt

FDA Gap Analysis & IND Readiness

You are a senior regulatory affairs specialist. Review the dossier and identify gaps relative to FDA 21 CFR Part 312...

Workflow

IND Submission 5-Step Pipeline

Step 1: Pre-IND meeting prep. Step 2: CMC documentation review. Step 3: Nonclinical gap analysis...

Prompt

NDA Cover Letter Generator

Draft a regulatory cover letter for an NDA submission including pathway designation and key claim summaries...

Skill

Regulatory Q&A Bot

You are an expert in FDA regulations. Answer questions with citations to relevant CFR sections and guidance documents...

Prompt

Safety Signal Detector

Analyze adverse event data and identify potential safety signals relative to the drug known risk profile...

Workflow

Drug Label Review Workflow

Step 1: Extract all product claims. Step 2: Cross-reference with approved clinical study data...

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