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. Each skill encodes a specialist research or analysis workflow that Claude follows step-by-step. Once installed, you just ask Claude your question in a normal chat (for example, "What are the PV requirements in Saudi Arabia?") and it uses the right skill automatically.
See the skills README for the full list and descriptions.
No technical knowledge is needed. You do this once per skill.
1. Download the skill you want (each link downloads a .zip file — do not unzip it):
| Skill | Download |
|---|---|
| Clinical 2×2 Study Analyzer | clinical-2x2-study-analyzer.zip |
| Pharmaceutical Regulatory Research | pharma-regulatory-research.zip |
| Pharmacovigilance Regulatory Research | pv-regulatory-research.zip |
| Serialization & Track and Trace Research | serialization-regulatory-research.zip |
| Veterinary Regulatory Research | vet-regulatory-research.zip |
2. Turn on code execution (one-time setup)
- Go to Settings → Capabilities and switch on Code execution and file creation.
- On a Team or Enterprise plan, your workspace owner may need to enable Skills and code execution for the organisation first.
3. Upload the skill
- Go to Customize → Skills.
- Click +, then + Create skill, then Upload a skill.
- Choose the
.zipfile you downloaded. - The skill now appears in your skills list. Make sure its switch is on.
4. Use it
- Start a new chat and ask your question in plain language.
- For the regulatory research skills, make sure Web search is turned on in the chat's tools menu — these skills look up current official sources.
- Claude will first ask a few questions about your product and situation. Answer them as best you can; the answers shape the whole report.
Tips
- One country per chat. For a multi-country comparison, research each country in its own chat, then compare the results.
- Updating a skill. The download links above always give the newest version (see Releases for what changed). To update, download the
.zipagain, delete the old skill from Customize → Skills, and upload the new one. - Upload failed? Make sure you uploaded the
.zipfile exactly as downloaded, without unzipping or renaming it.
Menu names on claude.ai change from time to time. If anything above doesn't match what you see, follow Anthropic's official guide: Using Skills in Claude.
For maintainers: pushing a change under skills/ to main automatically validates and packages every skill and publishes a new GitHub Release (workflow). To check a skill locally before pushing, run python3 scripts/package_skills.py (writes dist/*.zip, which is git-ignored).
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. Confirms the extracted numbers with you first, then uses a bundled calculation script for exact results. 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 that opens with a key-facts summary, then covers the regulatory framework, registration pathways, which foreign approvals are accepted (FDA, EMA, WHO, regional procedures, CPP), step-by-step procedures, required documents, timelines, pricing approval, official fees (local currency + USD), and go/no-go business considerations — tailored to the applicant's role (local manufacturer, foreign MAH, local agent, distributor, etc.). Includes an optional registration readiness checklist.
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, an optional compliance readiness checklist, and reference notes for GCC, EU, US, LATAM, and Africa.
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. Produces a report that opens with a key-facts summary and covers which authorities govern the product, registration pathways, which foreign approvals and dossiers are accepted, required documents, timelines, and costs. Accounts for multi-authority structures, species-specific requirements (MRL and withdrawal periods for food-producing animals), and vaccine batch release obligations. Includes an optional registration readiness checklist.