Case Study

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

Project Achievements

Successfully developed CEP and CER documents meeting all TGA requirements

Completed the project within tight timelines, ensuring timely submission

Received strong client appreciation for adaptability, quality, and proactive communication

Enhanced regulatory alignment through early issue identification and query resolution

Project Success

The combination of technology-driven processes, subject matter expertise, and clear collaboration between Celegence and the client ensured efficiency, accuracy, and regulatory compliance. The CAPTIS® Platform supported seamless coordination, literature review, and version control throughout the documentation process..

Need TGA-Compliant Documentation for Your Medical Device?

Celegence delivers CEPs, CERs, and regulatory support aligned with TGA requirements—powered by CAPTIS® and expert consulting to ensure timely, high-quality submissions. 📧 Email us at info@celegence.com

Learn More

Contact Us Today

From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

"*" indicates required fields

Phone
This field is for validation purposes and should be left unchanged.
Name*
First Last
Job Title*
Company Email**
Company Name*
Phone*
Industry**
Country*
Message*
Consent*
I agree to the privacy policy.
CAPTCHA
This field is hidden when viewing the form
Form Embed URL
This field is hidden when viewing the form
Lead Source*
This field is hidden when viewing the form
Visitor ID*
This field is hidden when viewing the form
First Page Viewed*