Regulatory Affairs
Regulatory Affairs is a critical function that ensures pharmaceutical, biotech, and medical device products comply with global health authority requirements. It involves the preparation, submission, and management of technical documents throughout the drug development lifecycle. Our regulatory professionals facilitate approvals by aligning scientific data with regulatory expectations.
CTD Module 2 Document Authoring
We specialize in writing high-quality summaries and overviews for Common Technical Document (CTD) Module 2, including:
- 2.3 Quality Overall Summary (QOS)
- 2.4 Nonclinical Overview
- 2.5 Clinical Overview
- 2.6 Nonclinical Summary
- 2.7 Clinical Summary
Summary of Change (SOC) Document Preparation
- Systematic comparison of current vs. previous versions
- Clear justification of each change (scientific, technical, or editorial)
- Regulatory language aligned with global authority expectations (FDA, EMA, MHRA, etc.)
- Seamless integration into variation, amendment, or renewal submissions
Health Authority Response Document Support
Timely and precise responses to health authority queries are crucial to regulatory success. We help you to craft effective, scientifically sound responses to inquiries from agencies such as:
- US FDA & EMA (Information Requests, Complete Response Letters)
- PMDA, Health Canada, TGA, and others