PharmaScribe

PharmaScribe

Your AI Regulatory Writing Assistant

Transform your study data into regulatory-compliant reports in minutes. Upload your tables, figures, and documents, and let AI generate publication-quality IND reports following FDA guidelines.

How It Works

Generate compliant reports in four simple steps

1. Upload Data

Upload your CSV tables, figures, and protocol PDFs

2. AI Generation

AI analyzes your data and generates a complete report draft

3. Refine with Chat

Use AI chat to refine and revise sections interactively

4. QC & Export

Run automated QC checks and export to Word or PDF

Supported Report Types

Generate all common IND filing report types with consistent formatting

Pharmacokinetics (PK)

Analysis of drug absorption, distribution, metabolism, and excretion parameters

Toxicology

Preclinical safety and toxicity study reports

Chemistry, Manufacturing & Controls

Drug substance and drug product characterization

Clinical Pharmacology

Human PK/PD studies and clinical pharmacology reports

Bioanalytical

Method validation and bioanalytical study reports

ADME

Absorption, Distribution, Metabolism, and Excretion studies

Pharmacology

Primary and secondary pharmacodynamic studies and safety pharmacology

Ready to Get Started?

Start generating your first IND report in minutes. No complex setup required.