Regulatory Consultation and Submissions
Everest has years of successful regulatory submission experiences. We have an in-house regulatory submission team as well as access to a large and growing network of former regulators, industry regulatory experts with broad experience and therapeutic area experts with deep technical expertise. Collectively they help plan and position your product regulatory path leading to smarter decisions and the best and most efficient course for a successful regulatory approval.
We will first assess your regulatory needs to successfully prepare and submit your application to regulatory agencies. Our assessment begins with listening to you and determining where you need to be through a gap analysis and setting the plan in place. We provide strategic analysis and path forward recommendations and are hands-on to assist in preparing agency communications and provide representation at health authority meetings. We can be your formal agency contact and support your filings through our SOP driven process and 21 CFR Part 11 compliant software. We follow the eCTD format and ensure your application (e.g. IND, NDA, BLA application to FDA) is compliant with all regulatory agency technical requirements (e.g. CTD backbone structure, document type, required files) so that your submission will swiftly pass technical validation and arrive to agency reviewers without delay.
- Gap Analysis – Review your past regulatory interactions, current CMC Information, Nonclinical and Clinical Studies, and assess for additional documentation or needed studies for your therapeutic area submission for a successful application approval.
- Meet with Health Authorities – Our experienced regulatory, medical, clinical, and biostatistical experts begin their involvement with the Gap Analysis and work with you to build your submission strategy, agency communications, and accompany you to meet with regulatory agencies.
- US Agent Representation – We can be your formal regulatory agent to the FDA, responsible for submissions and formal communications directly with FDA through the FDA Project Manager. This coupled with our submission processes provides a seamless interaction to agencies with prompt information relay to Client.
- Application Filings and Maintenance - Our work does not end with the initial submission of your application. We work closely with you to address agency responses and requirements as your application is reviewed. We keep your application current and compliant, filing all required submissions such as meeting requests and briefing packages, initial IND and follow-up submissions, protocol amendments, safety reports, annual reports, and other submissions as needed through the application lifecycle such as, for example, special protocol assessments, requests for advice, and cross-application submissions.
- Broader Scope and Depth of Our Regulatory Submission Support – Medical and Scientific Writing, and Biostatistics. Our Medical and Scientific Writing department is accustomed to supporting regulatory submissions. They follow ICH Guidelines in writing and publishing eCTD compliant submission documents such as protocols, CSRs, M2 Summaries, and briefing packages. Our Biostatistics and Statistical Programming department is proficient in supporting submissions from strategic planning, statistical planning for the overall clinical program, and protocol design, sample size determination, and statistical authoring, to performing integrated analyses and production of CDISC compliant submission ready dataset packages (including SDTM/ADaM Reviewers Guides and Define.xml files, and SDTM Annotated CRF) and tables/listings/figures.
- eCTD Publishing – Our Medical Writers and Document Publishing Specialists are fluent in all submission document requirements and publish high quality documents with appropriate levels of bookmarking and hyperlinking to provide agency reviewers with easy intuitive navigation within and between documents during submission review.
- Submission Method – We send submissions directly to regulatory agencies (e.g. FDA, EMA, and Health Canada) on your behalf, using submission gateways where available.
- Submission Experience – Everest has successfully submitted hundreds of eCTD submissions to regulatory agencies with zero technical validation findings to date.
- Submission Project Management – All submissions begin with a Submission TOC and a planned Submission Timeline. Everest prepares a Submission Inventory and Document Lifecycle Management Tracker, maintains a Submissions Log and a Regulatory Communications Log.
- New Applications or Application Transfers to Everest – Everest’s experience is divided equally between new application and applications that are already in progress with agencies. We have proven processes for a smooth transfer of an application from your in-house process or current vendor to Everest, and this may include transfer of submission communication responsibilities (e.g. US Agent) in addition to the transfer of technical submission responsibilities.