PEARA
Global AI

Regulatory practice. Evidence-led decisions.
A new generation of postgraduate simulation.

Open workspace PEARA AI e-CTD Training labs

US FDA · EU · Saudi SFDA · GCC / UAE · Egypt EDA

Cited drafts · Expert review

7 regulatory domains

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PEARA regulatory training

Build confidence in regulatory practice. Explore expert-led mini trainings and immersive postgraduate simulations, all in one learning environment.

Mini trainingsPostgraduate learningPractical simulations

Explore PEARA training

RegCopilot

Ask a question. Get a cited answer per authority, with differences flagged.

Classification

Device class and conformity route for all five authorities in one pass.

Pathway advisor

NDA, ANDA, 351(k), EU procedures, GCC and EDA reliance — side by side.

Change monitor

Regulatory updates tagged by product type and impact.

Requirement matrix

Country-by-country requirements, exportable to Excel.

Audit trail

Every AI output logged with model version and timestamp.

Seven domains, one core

Medical devices & IVDs

Classification, 510(k) predicates, GSPR, ISO 14971 risk files, UDI.

Drugs

NDA, ANDA, 505(b)(2), EU procedures, CTD Module 2, variations.

Biologics & biosimilars

Comparability, totality of evidence, interchangeability, 351(k).

Cosmetics

Ingredient screens, claims, CPSR/PIF, MoCRA listing.

Combination products

PMOA, lead center, Article 117, 21 CFR Part 4 cGMP.

Pharmacovigilance

ICSRs, MedDRA coding, narratives, PSUR/PBRER, RMP, signals.

Clinical trials

ICH E6(R3) protocol checks, CTA packages, ICFs, SUSAR/DSUR.

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