PHARMACEUTICAL INDUSTRY SERVICES
eCTD Preparation
The electronic Common Technical Document (eCTD) has become the standard for numerous regulatory agencies across the world.
SPL Preparation
Structured Product Labeling (SPL) is a document markup standard approved by Health Level 7 and adapted by FDA as a mechanism to exchange product information.
Systems Validation
Team Tranquil provides full range of support and assistance to industries regulated by FDA in meeting 21 CFR Part 11 compliance.