Avoid Rejection. Assure Submission Success.
Looking to assure error-free eCTDs? We can help. GlobalSubmit’s REVIEW™ and VALIDATE™ products are used exclusively by the FDA and preferred by top pharmas and biotechs worldwide. Our user friendly interfaces make it fast and easy for you to navigate through, organize and submit your NDA, IND and other electronic submissions. You may be asking yourself how GlobalSubmit knows what it takes to make an eCTD submission successful. Well, we know because we work with the FDA and other regulatory agencies around the world. They give us insight into the wants and needs of their reviewers. We know because we’re active participants in the International Conference on Harmonisation, HL7 and other regulatory protocol-setting organizations globally. We know too, because we hold advisory councils where we ask you to tell us what you need our products to deliver.
And we know because our principals are the thought leaders in the industry.
According to the FDA, the number-one reason for approval delays is poor communication. Poor communication happens when you see information one way and the Agency sees it another. It happens when your perception of what your eCTD should look like has nothing to do with the reality of the thing.
REVIEW is the premier software application designed exclusively for the effective review of eCTD electronic submissions.
REVIEW allows users to view their submission for technical accuracy while easily navigating submission to see all regulatory activity.
Global Submit’s VALIDATE™ software has built-in features that assures eCTD submission success. Its features of advanced processing and effective error checking are designed to help users create and submit quality eCTDs. Global Submit’s Validate ensures that your your submissions are compliant with the latest FDA regulatory guidelines.
PUBLISH is designed to simplify previously complex tasks thus eliminating confusion. With PUBLISH, you can perform tasks efficiently and reduce time and effort. PUBLISH gives publishers clear direction as to the best procedures for complying with ICH and regional authority guidance. PUBLISH helps in submitting eCTD as quickly as possible.
Take a look at this first:
If one of these companies sounds like you, you may want to talk to us about eCTD Readiness.
Company A: A medium-sized pharma ready to move from paper to outsourced eCTD, but doesn’t understand impact or best practices.
Company B: A small biotech about to produce its first IND. It needs to choose a publishing partner and understand what it needs to do to interact efficiently with that partner.
Company C: A pharma that's been using a publishing partner for several years and needs to decide whether to bringpublishing in-house. If publishing moves in, the company needs to understand the impact on its people, processes and technology.
Company D has decided to bring publishing in-house, and needs to choose a tool, develop processes and train staff.
Although these companies are at different stages and making different decisions, there is a common thread:
They need education on requirements and best practices to make sound decisions and develop comprehensive and realistic plans
Their in-house resources are unlikely to have the time and experience needed to proceed in an efficient manner
They are all facing risk – and anticipating benefit
GlobalSubmit’s targeted eCTD Readiness services can help all these companies overcome their challenges, reduce risk and cost, maximize benefit and achieve realistic and meaningful eSubmission goals. Our approach is flexible and collaborative:
Working with you beforehand, we strive to understand your current state and goals
We present an educational and planning workshop with materials tailored towards your education and planning needs, respecting your goals and constraints
We work with you to decide what deliverables you want to produce and what deliverables you want GlobalSubmit to produce
Final gap analysis, project plan, RFI/RFP for publishing software or services, SOPs and work practices, eCTD handbook, templates, training materials, etc.
Regardless of who produces the deliverables, our accelerators (template plans, checklists, handbooks, RFIs, etc.) will allow high-quality materials to be created in a cost-effective manner
Together, we will:
Define what eCTD-ready means to you
Ensure that you have a solid and practical knowledge of eCTD regulations, guidance and best practices to serve as a basis for decision-making
Establish a road map with specific and actionable tasks and milestones
Assist you as needed with vendor or partner selection for publishing
Create awareness of the changes that will be needed at the levels of the individual and department
Talk to us about how our project accelerators, expertise and industry experience can help you reduce risk, maximize benefit and result in a realistic, actionable plan. Talk to us about how our project accelerators, expertise and industry experience can help you reduce risk, maximize benefit and result in a realistic, actionable plan.
Arable Corp’s targeted eCTD Readiness services can help companies overcome their challenges, reduce risk and cost, maximize benefit and achieve realistic and meaningful eSubmission goals. Working with you beforehand, we strive to understand your current state and goals
We work with you to decide what deliverables you want to produce and what deliverables you want us to produce. Regardless of who produces the deliverables, our accelerators (template plans, checklists, handbooks, RFIs, etc.) will allow high-quality materials to be created in a cost-effective manner
Life science companies must respond quickly to changes in global regulatory requirements. Our team of experts helps you optimize your existing submission procedures and perfect your eCTD submission process. Our experts can assist you not only with your product installation, but with integrating your solution with other IT systems, such as electronic publishing or regulatory tracking applications.
We understand the unique requirements for implementation and use of regulatory content management systems and provide focused expertise. Benefits are derived by way of increased efficiency, easily access eCTD Expertise, accelarate publishing process, improve eCTD technical accuracy, and get the competitive advantage.
Arable Corp can support your eCTD publishing needs as we have an extensive experience with leading publishing tools and offer comprehensive eCTD review and validation using our software suite.
Through our partnerships with other organizations, we are able to offer an impressive collection of services covering every aspect of the regulatory publishing process, from writing and editing assistance to submission document migration. The services that we cover include the following:
Scan/Input Capture Services
Standardization of Documents to Support eCTD Format
Document Template Creation & Management
Document Amendments, Revision & Resubmission
Assembly & Quality Checking of eCTD Documents
Technological advancements make it possible for life science companies to easily transition from paper to eCTD. We at Arable strongly advocate the integration of leading technologies to guarantee a well-rounded approach to the adoption of electronic submissions.
The range of IT solutions that we cover include:
Enterprise Content Management
Digital Signature Solutions
Clinical Information Management Systems
RAPIDSTART IMPLEMENTATION SERVICES:
We expedite eCTD submissions through our RapidStart Service which is designed to run Validate Application quickly. We accelerate your process by consulting with you to identify the integration and implementation services that will work best for your organization. We take great care to certify total compliance with your internal system guidelines and also include training services that educate you in Best Practices so you can submit eCTDs with confidence. Using our industry expertise and eCTD domain knowledge, you’ll expedite your processes and save valuable turn-around time on your submissions.
eCTD PILOT™ Program
Arable’s eCTD quality suite is made available to you pre-installed on a virtual machine or laptop. Analyzing your submission with our VALIDATE™ software ensures that critical technical errors are found before you submit to the FDA, using the exact criteria they use. You'll also review your submission in REVIEW™, allowing you to put yourself in the position of FDA reviewers. By seeing what they'll see, you'll ensure that they'll be able to effectively navigate your submission and locate crucial information in a timely manner.
One of our industry experts will help you the entire time by showing you how to use the software, reviewing your submission, and providing insight on best practices and common problems and issues
Our learning materials are timely, well thought out pieces of information that you can choose to access or not, depending upon your needs. For large scale deployments it might not be advisable to get your team in one location that is why we have an offering of train the trainer where a student becomes the teacher. We impart training and educate associates on the ins and outs of eCTD for a deeper level of understanding. After our instruction, GlobalSubmit trainees get the “green light” to train others in your organization.
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