Regulatory Submission Generator

Create a Professional Regulatory Submission in 2 Minutes

No more blank page syndrome. Describe your product and get a complete, professionally formatted regulatory submission — ready to use.

Under 2 minutes
Industry compliant
PDF & DOCX export
All sections included

Free plan includes 2 documents/month · No credit card required

What's Included

Everything in Your Regulatory Submission

Complete, professional documentation — no sections missing

01

Applicant Information

02

Product Description

03

Regulatory Classification

04

Standards and Requirements

05

Testing and Evidence Summary

06

Risk Analysis

07

Labeling and Instructions

08

Post-Market Plan

Why SpecIQ

Why Teams Choose SpecIQ
for Regulatory Submissions

Agency-specific document structures
Evidence and data summaries
Risk-benefit analysis sections
Compliance declarations
Post-market surveillance planning
Speed Comparison
10×
Faster Than Manual
Manual creation4–8 hours
With SpecIQ2 minutes
Industry Use Cases

Regulatory Submissions for Every Industry

Medical Devices

510(k) premarket notification documentation

Pharmaceutical

Drug registration and NDA supporting documents

Consumer Products

CE marking technical file documentation

FAQ

Frequently Asked
Questions

Can't find what you're looking for? Reach out to our support team.

SpecIQ generates submission documents aligned with FDA, CE/EU MDR, EPA, PMDA, TGA, and other major regulatory frameworks.

Generate Your Regulatory Submission
in minutes, not hours.

Join professionals who create their regulatory submissions with SpecIQ. Complete, structured, ready to use.

2 free documents
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