AI Fundamentals in Regulatory Affairs

1. Evolution of Regulatory Affairs & Digital Shift
2. LLMs, Prompt Engineering & Regulatory Intelligence
3. AI-based Regulatory Pathway Mapping
4. Careers: Regulatory Associate, AI Regulatory Analyst, Swalife Regulatory Prompt Studio – Walkthrough  and Consulting: Entry into Swalife Regulatory Projects

 

AI for Product Classification & Regulatory Strategy

1. Drug vs Nutraceutical vs Cosmetic vs Device
2. AI-assisted product classification logic
3. Classification dossier for Swalife PureHerb
4. Careers: Regulatory Strategy & Product Lifecycle Roles, Swalife Regulatory Prompt Studio – Walkthrough  and Consulting: Client advisory on product classification

AI for CTD / eCTD Dossier Authoring

1. CTD & eCTD structure explained
2. AI-assisted Module 1–5 drafting
3. Module 2 Quality Overall Summary
4. Careers: Dossier Writer, Regulatory Author, Swalife Regulatory Prompt Studio and Consulting: Outsourced dossier services via Swalife

AI in CMC & Quality Documentation

1. Regulatory expectations for CMC
2. AI for specs, stability & batch documentation
3. Hands-on: CMC narrative creation and CMC summary for herbal formulation
4. Careers: CMC Regulatory Specialist, Consulting: CMC documentation services and Swalife Regulatory Prompt Studio

AI in Preclinical & Toxicology Regulatory Writing

1. Non-clinical regulatory frameworks
2. AI-driven tox & safety report structuring
3. Project: Preclinical regulatory summary
4. Careers: Preclinical Regulatory Associate, Consulting: Safety documentation & justification and Swalife Regulatory Prompt Studio

AI in Clinical Trial Regulatory Submissions

1. IND / CTA / Ethics submission basics
2. AI-assisted protocol & IB drafting
3. Project: Clinical synopsis for observational study
4. Careers: Clinical Regulatory Affairs Specialist, Consulting: Clinical documentation & EC support and Swalife Regulatory Prompt Studio

AI in Decentralized & Observational Trials

1. Regulatory view of decentralized trials
2. AI for RWE & protocol justification
3. Regulatory justification document
4. Careers: DCT & RWE Regulatory Roles, Consulting: Observational trial advisory and Swalife Regulatory Prompt Studio

 

AI in Pharmacovigilance & Safety Reporting

1. PV regulations & compliance landscape
2. AI-based signal detection & narratives
3. PSUR / ADR narrative
4. Careers: PV Scientist, Safety Officer, Consulting: PV outsourcing & reporting services and Swalife Regulatory Prompt Studio

AI in Regulatory Intelligence & Global Compliance

1. Global regulatory monitoring systems
2. AI-based horizon scanning
3. Hands-on: Regulatory intelligence dashboard and Global impact assessment report
4. Careers: Regulatory Intelligence Analyst, Consulting: Subscription-based intelligence services and Swalife Regulatory Prompt Studio

AI in Labeling, Claims & Promotional Review

1. Labeling & claim regulations
2. AI-assisted claim risk analysis
3. Hands-on: Label & leaflet review and Claim compliance report for Swalife product
4. Careers: Labeling & Compliance Specialist, Consulting: Marketing compliance advisory and Swalife Regulatory Prompt Studio

AI in Regulatory Inspections & Audits

1. Inspection readiness & audit lifecycle
2. AI-based gap analysis & CAPA
3. Mock audit & readiness checklist
4. Careers: Audit & Compliance Manager, Consulting: Inspection readiness services and Swalife Regulatory Prompt Studio

 

AI-Driven Regulatory Leadership & Consulting Mastery

1. Regulatory leadership & decision frameworks
2. AI-enabled regulatory consulting models
3. End-to-end regulatory strategy
4. Careers: Head of Regulatory / Global Roles, Consulting: Swalife consultant onboarding & revenue sharing and Swalife Regulatory Prompt Studio

 “India’s first AI-driven Regulatory Affairs Talent & Consulting Platform”