Submission Services
Apyx's comprehensive submission services manage the document lifecycle from authoring through submission publishing in both electronic and paper formats. We also provide project-based services, including building internal eCTD capabilities; legacy document scanning and preparation; electronic document (CRF, CSR, nonclinical, CMC) preparation; document migration (into EDMS) and collaborative on-site support for your organizaton's Regulatory Operations team.
Apyx services are designed to provide emerging to mid-size biopharma with the same high quality regulatory operations support available to large pharma without the need to buy, implement and validate expensive document management and publishing software or hire and train operations and technical staff to support it.
Apyx's services for large pharma are designed to complement the services provided by internal regulatory and therapeutic area operations departments and maximize their efficiency. Services support all aspects of preparing for and executing a successful submission project anywhere along the regulatory document lifecycle from authoring through dossier compilation and maintenance.
Regulatory submissions are inherently complex projects, and we are experienced in all components of the submission process to manage it both efficiently and cost effectively and meet all deadlines. We understand every nuance in the regulations and are thoroughly familiar with all applicable FDA and ICH guidances. We will lead and manage disparate departments and stakeholders within your organization-- clinical, nonclinical, CMC, regulatory, and others-- to support your broader submission goal and timelines.
Submission Services
- Document-level: rendering and scanning, image clean-up, report-level publishing/e-sub document preparation, word processing and document formatting and assembly
- Submission-level Publishing and Dossier Compilation
- Submission Lifecycle Maintenance (eCTD, NeES, Paper)
- eCTD hosting and viewing
- Hosted Regulatory Document Management
- SPL R4 submissions: Product Label (including Drug Listing section), Establishment Registration, NDC Labeler Request
- Data formatting per the FDA 1999 or CDISC SDTM guidances
Apyx produces original applications and amendments in every format: eCTD, NeES and Paper.
Apyx is experienced in the full spectrum of international submissions: NDA, BLA, MAA, IND, CTA, IMPD, ANDA, sNDA, Amendments, Variations, Supplements, Annual Reports, Renewals, DMFs, routine agency correspondence and more.
Experience Overview
- Over 400 eCTD submissions created, validated, submitted and accepted at various Health Authorities world wide
- Over 400 eCTD submissions transmitted via Apyx's established electronic submissions gateway with FDA
- Successfully submitted INDs, NDAs (including 505B2 NDAs), BLAs, ANDAs, MAAs and a variety of amendments and variations in eCTD format
- Assisted 15 emerging to mid-size clients through the process of creating and submitting their first electronic submission in eCTD format
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News & Events
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.