Med-Reg AI Guide

Built for medtech and biotech professionals โ€” simplify FDA, CDSCO, EU MDR, and WHO regulatory steps with real-time, intelligent guidance.

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Supported Regulatory Bodies & Pathways

USA

US FDA

๐Ÿ‡บ๐Ÿ‡ธ USA

NDAANDA510(k)De NovoPMA
India

CDSCO

๐Ÿ‡ฎ๐Ÿ‡ณ India

SUGAMMD-14Form 44
Europe

EU MDR

๐Ÿ‡ช๐Ÿ‡บ Europe

Class IClass IIaClass IIbClass III
Global

WHO PQ

๐ŸŒ Global

Vaccine & medicine prequalification
Global

ICH GCP

๐Ÿงช Global

Clinical trial protocols
Australia

TGA

๐Ÿ‡ฆ๐Ÿ‡บ Australia

Prescription MedicinesMedical DevicesOTCComplementary Medicines
Canada

Health Canada

๐Ÿ‡จ๐Ÿ‡ฆ Canada

NDSANDSDINMedical Device License
New Zealand

Medsafe

๐Ÿ‡ณ๐Ÿ‡ฟ New Zealand

Consent to Distribute MedicinesProduct Registration
United Kingdom

MHRA

๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

Marketing AuthorisationUKCA MarkClinical Trial Authorisation

Key Features

Explore how LexaMed empowers your regulatory and drug discovery journey with intelligent tools designed for biotech & medtech startups.

Automated Document Checklists

Instant, pathway-specific checklists tailored to NDA, 510(k), PMA, EU MDR, CDSCO, and more. Stay audit-ready effortlessly.

Real-Time Regulatory Timeline Support

Visual roadmaps and milestone alerts ensure you never miss a deadline. Timelines adjust automatically as your project evolves.

AI-Powered Cost Estimator

Predict regulatory submission costs based on historical and current data, customized to your product and region.

Compliance Recommendation Engine

Get intelligent suggestions to fix compliance risks and align your submissions with best practices.

Multi-Region Support

Navigate global regulations from a single dashboard: US FDA, EU MDR, CDSCO India, and WHO/ICH guidelines.

Why Use Lexamed AI?

LexaMed AI simplifies complex global regulations and accelerates drug discovery with AIโ€”empowering small health-tech innovators to move faster, smarter, and safer.

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