Pre-IND or INTERACT Meetings
We provide full presubmission support for Pre-IND or INTERACT meeting requests and/or briefing packages, including an eCTD readiness assessment, assistance defining metadata, planning ICH granularity, and file naming conventions, as well as Word formatting, PDF publishing and external/cross-document hyperlinking to literature references, and dispatch of the final eCTD output via our pre-established FDA Electronic Submission Gateway (ESG) WebTrader account
IND Original Applications
We specialize in publishing of initial IND applications for both CDER and CBER, including Word formatting, PDF bookmarking and internal/external hyperlinking, assistance defining regional, CMC, and STF metadata, planning ICH granularity and file naming conventions, as well as performing a CDISC dataset gap analysis, and an internal review of all documents (along with a sponsor review) for accuracy and compliance with the current FDA eCTD validation criteria
Lifecycle Maintenance
We can continue or inherit the lifecycle management of pre-existing IND, NDA, BLA, ANDA, DMF or BB-MF applications with pre-approval or post-approval status, including IR responses, protocol amendments, IB updates, new investigator information, other types of information amendments, SUSARs, annual reports or periodic safety reports, supplements, amendments to supplements, PMR/PMC status updates, promotional material, general correspondence submissions, and more
Ad-hoc Publishing or Consulting
We offer ad-hoc publishing for companies that need overflow submission support, or assistance preparing eCTD submission-ready Clinical Study Reports (CSRs) and Subject Case Report Forms (CRFs)
We also offer consulting for companies that are looking to establish an in-house regulatory operations team and need help evaluating eCTD software vendors, hiring and/or training publishers, and drafting internal SOPs, work instructions, and formatting or publishing style guides
