Australia TGA Compliance Support for a Dental Implant Device Manufacturer

Project Summary

A dental implant device manufacturer partnered with Celegence for medical writing and regulatory consulting support to prepare a Class IIb submission to the Therapeutic Goods Administration (TGA), Australia. The project involved developing TGA-compliant Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). Using Celegence’s proprietary CAPTIS® Platform, literature reviews and expert collaboration were streamlined for efficient, high-quality documentation tailored to TGA requirements.

Highlights:

Authoring CEPs and CERs in accordance with TGA compliance guidelines

Assessing adequacy of clinical data based on product history, pre-clinical and clinical studies, complaints, AEs, and literature

Conducting systematic literature searches, appraisals, and State-of-the-Art reviews to benchmark safety and performance

Maintaining quality through multi-level internal reviews and QA processes

Evaluating the need for PMCF activities and integrating findings where applicable