Approval

Approval pathways.

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First-class regulatory submissions require the hightest quality medical writing. Meditrial medical writing and regulatory teams produce reports and submissions that meet the standards of the most exacting regulatory agencies in the world.
We'll work with you to plain, prepare and complete submissions and will communicate, interact and liaise with regulatory agencies to ensure approval on time.

Medicinal products

National and international regulatory strategy
Communicate, interact, and liaise with EU and US regulatory agencies
Preparation of Clinical Trial Applications
New EU pharmaceutical legislation
EUDRA-CT number request
US Regulatory submission (IND, CTA, NDA, CTD, eCTD, DMF, ANDA)
Comprehensive CTD and eCTD capabilities
Risk management / Pharmacovigilance

Medical devices

Regulatory strategy for CE marking & US submissions
Technical file preparation
Risk analysis
Clinical evaluation
Labeling - product leaflets - instructions for use
Patient information & advertising
Contracts
Quality system compliance
Medical Device Vigilance
European Authorized Representative