A collection of open-source scripts, tools, and AI skills to aid in pharmacovigilance, regulatory affairs, and clinical research.
Location: HighLit/
An Excel/VBA tool that speeds up safety literature review in pharmacovigilance. It highlights safety-relevant keywords across literature abstracts and full-texts to help analysts quickly identify potential adverse event case reports — in line with EU GVP Module VI weekly literature monitoring requirements.
Key features:
- Highlights and colorizes safety keywords (severity, toxicity, study type, special populations)
- Identifies targeted medicinal products
- Flags potential case reports, meta-analyses, systematic reviews, and animal/in-vitro studies
- Converts PubMed
.txtexports into formatted, highlighted Word documents - Fully customizable keyword and drug lists
See the HighLit README for installation and usage instructions.
Location: skills/
A set of structured AI skills for use with Claude Code. Each skill encodes a specialist research or analysis workflow that Claude follows step-by-step.
See the skills README for the full list and descriptions.
Location: skills/clinical-2x2-study-analyzer/
Extracts binary outcome data from clinical study text and produces a full epidemiological analysis: 2×2 contingency table, relative risk, odds ratio, absolute risk reduction, NNT/NNH, 95% confidence intervals, and chi-square or Fisher exact tests. Outputs publication-ready tables and manuscript summaries.
Location: skills/pharma-regulatory-research/
Researches pharmaceutical product registration requirements for any country. Produces a business-plan-ready report covering registration pathways, step-by-step procedures, official fees (local currency + USD), timelines, and go/no-go business considerations — tailored to the applicant's role (local manufacturer, foreign MAH, local agent, distributor, etc.).
Location: skills/pv-regulatory-research/
Researches pharmacovigilance obligations for any country. Covers QPPV/local PV contact requirements, PSMF, expedited ICSR reporting timelines, PSUR/PBRER schedules, signal management, risk management plans, literature monitoring, and whether international documents (EU PSUR, EU RMP, E2B(R3)) are accepted locally. Includes a consolidated PV obligations summary table and an optional compliance readiness checklist.
Location: skills/serialization-regulatory-research/
Researches serialization and track & trace requirements for any product category in any country. Covers unique identifier structure, barcode/label technical specifications, aggregation, supply chain obligations by role, national repository registration, anti-counterfeiting requirements, implementation timelines, fees, and penalties. Includes reference tables for EU FMD/EMVS, US DSCSA, EAEU MDLP, GCC (Tatmeen/Salama), LATAM, Africa, and India.
Location: skills/vet-regulatory-research/
Researches veterinary product registration requirements for any country across all product categories — medicines, vaccines, medicated feed, feed additives, nutritional supplements, diagnostics, disinfectants, and pet food. Accounts for multi-authority structures, species-specific requirements (MRL and withdrawal periods for food-producing animals), and vaccine batch release obligations.