Regulatory Submissions
We deliver regulatory submissions with technical precision, seamless project management, and integrated cross-functional expertise.
Submission Execution for your Product Lifecycle
We provide comprehensive regulatory support to ensure your submissions are accurate, compliant, and on time. Our experienced team works seamlessly across regulatory, clinical, scientific, and statistical domains to deliver end-to-end submission services tailored to your product lifecycle.
What We Offer
Health Authority Interactions
Our regulatory, medical, clinical, and biostatistical experts prepare you for successful meetings with global health authorities—and accompany you to them. Read more about our strategies for regulatory agency meetings here.
Regulatory Agent Representation
We serve as your official representative with health authorities worldwide, ensuring clear communication and compliant submissions. We act as your U.S. Agent with the FDA, manage European submissions including CTIS clinical trial applications, and also support filings with Health Canada. With global experience across major regulatory bodies, Everest streamlines interactions, reduces complexity, and keeps your applications moving forward.
Integrated Regulatory Submission Support
Our Medical and Scientific Writing team crafts ICH-compliant documents (e.g., protocols, CSRs, Module 2 summaries, and briefing materials), while our Biostatistics experts provide full submission support from statistical planning to integrated analysis, including SDTM/ADaM datasets, Reviewer Guides, Define.xml, and more.
eCTD Publishing and Submission Execution
Our publishing specialists prepare technically flawless, fully bookmarked and hyperlinked eCTD submissions for FDA, EMA, Health Canada, and other global agencies—delivered via secure submission gateways where available.
Submission Project Management
Each submission is initiated with a Table of Contents and a detailed timeline. Everest prepares a Submission Inventory and Document Lifecycle Management Tracker, maintains a Submissions Log and a Regulatory Communications Log.
Application Filings and Lifecycle Management
Everest supports all follow-up submissions—meeting requests, briefing packages, INDs, protocol amendments, safety reports, annual reports, SPAs, cross-application submissions, and more—ensuring your applications remain current and compliant throughout their lifecycle.
Why Choose Everest for your
Regulatory Submissions?
Flawless Execution
We’ve delivered hundreds of eCTD submissions with zero technical validation findings.
Cross-Functional Expertise
Agency-Ready Documents
Global Experience
Streamlined Communication
