Regulatory Consulting & Writing
Our Regulatory Affairs team can support any project whether it is just getting off the ground or has post-market needs
Why Choose GLOBAL for
Regulatory Consulting & Writing?
The regulatory demands of clinical trials are complex and always changing. Here at GLOBAL our regulatory experts assist teams navigate workflows with ease. Our Regulatory Affairs team can support any project whether it is just getting off the ground or has post-market needs.
to Meet Your Research Needs
Early and critical strategic work must take place in the regulatory setting by assuring proper country selection for maximal enrollment with reliable data. The Global team can assist with the regulatory strategy development, provide services for local and national regulatory agency submissions and keep you in compliance with reporting requirements for each geography.
For FDA submissions, we can support and provide proper documentation for the process, all the way from early Q-sub meetings to final submissions and support with FDA panels and labeling negotiations. If you need a post-market study in any geography, we can support that too.
Some of our Consulting services include:
Country Submissions (US and OUS)
Central/Local IRB/EC Submissions
Support for FDA pre-sub meetings and filings
FDA Panel Support
Regulatory Audit preparation/support
Special status filings with FDA such as breakthrough designation and STEPs
Key Regulatory Writing Documents
- Investigator New Drug Applications (INDs) and Clinical Trial Applications (CTAs) - Applicable Common Technical Document (CTD) summary modules, including the following: o General Investigational Plan o Nonclinical overview (Module 2.4) o Nonclinical written summaries (Modules 2.6.1, 2.6.2, 2.6.4, and 2.6.6) o Nonclinical tabulated summaries (Modules 2.6.3, 2.6.5, and 2.6.7) o Nonclinical study reports (Module 4.2)
- New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs) - Applicable CTD summary modules, including the following: o Clinical Overview (Module 2.5) o Clinical summaries (Modules 2.7.1 through 2.7.6, including Integrated Summary of Safety [ISS] and Integrated Summary of Efficacy [ISE] modules) o Tabular listing of all clinical summaries (Module 5.2) o Clinical study reports (Module 5.3)
Other Health Authority Communications
- Orphan Drug Designation requests - Breakthrough Therapy Designation request
Safety Management & Pharmacovigilance/ Aggregate Safety Reporting)
- 120-Day Safety Update Reports - Development Safety Update Reports (DSURs) - Periodic Safety Update Reports (PSURs) - Periodic Benefit-Risk Evaluation Reports (PBRERs) - Patient Safety Narratives* * also under “Clinical Documents”