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| CONSULTING SERVICES |
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| We can provide a variety of regulatory consulting services to support your regulated submission creation and maintenance efforts. |
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| Management and staff awareness presentations |
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Providing presentations for senior management on the advantages of eCTDs; why it is important to have a strategy in place now for transitioning to electronic filing in the future.
On-site program to facilitate awareness and understanding of the practical issues and challenges that arise in the implementation of eCTD. Practical examples of lifecycle management. Case studies, metadata gathering activities and exploration of common submission scenarios will reinforce presentation topics in this one-day course. |
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| Analysis, eCTD readiness assessment |
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| We have a comprehensive program to determine your organization’s readiness to prepare and submit an IND or marketing authorization. We will review pipeline, schedules, and management goals. We will review the systems, tools, and personnel to understand what changes or additions, if any, are necessary. The readiness analysis report will provide a roadmap for what you need to do, and when you need to do it based on resources and schedule. SCG will identify process change and improvement needs in order to proceed towards eCTDs. |
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| Getting started, Best practices |
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Training for your staff on how to organize and structure documents for electronic submissions. We can provide customized document templates for summary and CMC documents ensuring format consistency and ease of applying standard section numbering.
Document formatting and how to organize the submission content to: |
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—Recognize and justify document granularity
—Be familiar with the structure of documents in a traditional NDA/eNDA, BLA/eBLA or CFR 312.23 IND and how they map to CTD/eCTD
—Organize metadata and recognize the Study tagging file valid values and where and when to use them.
—Understand the clinical data standards (SDTM, CDISC)
—Understand the new nonclinical data standards (SEND) and impact on your organization |
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| PUBLISHING SUPPORT SERVICES |
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| Providing a range of services and expertise for your regulated document needs. Whether you are planning an IND or in the middle of a marketing authorization application we can help. |
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| Project Management |
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| Every marketing application effort requires a diverse set of contributors, subject matter experts, authors, and a variety of internal and contract resources. You may only need help coordinating schedules, ensuring timely delivery of materials, or following up with authors and contributors. We can provide project management expertise working with you and your team. |
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| Report formatting, make submission-ready |
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| Formatting clinical study reports, applying ICH E3 granularity; rendering documents to PDF; standardized bookmarking and hyperlinking. We will work with your authors, medical writers, CROs and contract writers to ensure consistency of documents throughout the organization and compliance with agency guidelines. We can provide customized MSWord templates for the most common eCTD sections. |
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| Staff augmentation |
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| We have experience with leading eCTD publishing systems and can provide knowledgeable personnel to assist your team to complete specific tasks required at key stages in the submission process. Furthermore, if you have engaged another outsource service provider we can assist in preparing documents and reviewing the submission for conformance to industry standards and agency guidelines. |
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| Scanning, bookmarking, hyperlinking |
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| Case Report Forms; legacy nonclinical and clinical reports; CMC documents. We provide competitive document scanning, bookmarking and hyperlinking services. |
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| Submission lifecycle management (LCM) |
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| The eCTD specifications provides standard mechanisms for updating content and deleting obsolete information. But to take full advantage of the functionality of LCM it is important to structure your submission carefully, which we do. |
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| DOSSIER PUBLISHING: submission creation, management, delivery to authorities |
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| We operate a world class regulatory publishing system. We can build your submission in paper or electronic format and deliver it to you electronically via our secure file share, or CD or DVD. |
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| Supports US, Canada and European eCTD specifications |
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| We support NDA, BLA as well as legacy eNDA and eIND formatted applications. We can produce paper in addition to fully compliant eCTD submissions. |
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| Supports Non-electronic eCTD Submission (NeeS) formats |
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| Many regulatory authorities outside Europe and North America do not yet accept eCTD marketing authorization. The most common electronic format is NeeS (non-electronic eCTD Submission) a simplified structure requiring PDF Tables of Contents and omitting life cycle management. We can build these as well. |
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| Supports paper archive and agency compliant paper submissions |
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| Some authorities still require a paper archival copy, Australia’s TGA for example. Some authorities only accept paper applications. We work closely with commercial printers and freight forwarders in Northern California to print, bind, tab and ship your submission. We support both US Letter and A4 paper sizes. |
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| ESG account and pilot |
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| We can submit your NDA, BLA and IND sequences through the FDA’s secure electronic submissions gateway (ESG). In addition, we can help you prepare the required documentation plus a sample submission to the FDA to establish your own ESG account. |
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| Legacy applications |
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| eNDA, eBLA, eIND, paper INDs with electronic review copy. If you in-license or otherwise inherit a marketing authorization done in a legacy electronic format, you do not need to upgrade to eCTD. You can continue to amend, update and file annual reports in eNDA. |
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