ACUTA Regulatory and Clinical Services (ARCS)
At ACUTA, we offer you something distinctive and unique. Along with solutions offerings, we partner with our clients to achieve mutual success. ACUTA Regulatory and Clinical Services (ARCS) experts are available to work with you to create the optimum solution for your specific situation. As an industry expert in regulatory submissions (both electronic and paper), ACUTA provides technical competency with industry recognized solutions, and extensive experience with large and small Life Sciences companies. Our experienced ARCS team has the skills and technology to transform your paper-based submission into a fully compliant e-Submission. Whether you need help transforming your legacy data to e-Submission format or assistance in compiling your e-Submission, our ARCS team is a very capable and efficient option.
ARCS Process and Workflow
Our goal is to make your overall process easy, smooth, and efficient. Just as important is to have access to your information from anywhere in the world 24x7. The figures above illustrate how we manage your application(s) and submissions from start to end. In the initiation phase, we create your portal in SharePoint, which is where we will keep documents that go into a submission. The SharePoint portal is your dedicated site to manage your submission documents. This site serves as your document management and collaboration center where multiple people from your organization contribute to the content you expect to include in a submission to an agency. Also, in this phase we introduce our ARIM (ACUTA Regulatory Information Management) System which will provide you access to all applications/submissions that are in process as well as submitted to an agency. Whenever you would like to view a document, submission, or entire application you will find them here.
Your Partner for Success
Whether we simply supplement your existing resources at peak times, help your personnel acquire knowledge or provide you with complete electronic submissions, our Regulatory and Clinical Services Group can help you increase efficiency, reduce the cost of developing your infrastructure and system architecture, and minimize your overhead.
In a stringent and exacting regulatory environment, we offer you access to recognized industry specialists which, combined with our proven software solutions, deliver compliant, timely and effective electronic submissions. Our ARCS' team members have helped many companies with their regulatory activities supporting multiple formats required by the agencies around the world. We can assist you with all your regulatory operations activities such as
- Submission management.
- Regulatory dossier compilation, publishing and submission to agency.
- Pre-approval life-cycle maintenance.
- Post-approval life-cycle maintenance.
- Submission FDA, EMA and Health Canada via gateway.
Our ARCS team has extensive experience in preparing documents for submission readiness, using our knowledge and intuitive Adobe® Plug-in tools (ACUTA PDF Tools), we can help you meet your submission deadlines.
Our experienced ARCS team has the skills and technology to transform your paper-based submission into a fully compliant eSubmission or create one from scatch from your documents. Whether you need help transforming your legacy data to an eSubmission or assistance in compiling your eSubmission, our ARCS team is a very capable and efficient option. Our services include, but are not limited to, the following:
- Regional eCTD guidance consultation.
- PDF publishing.
- Document and submission quality control activities.
- eCTD compilation.
- Clinical Study Report (CSR) Publishing.
- Submission Data to the FDA.
- Submission to the Regulatory Authorities.
- eCTD XML backbone validation services.
- SPL and PLR labeling conversion.
- Submission preparation evaluation service.
Thinking about switching from paper based IND to eCTD?
You can switch over to eCTD without infrastructure changes and huge investment in hardware and software. Our ARCS members are there to assist you along the way. Contact us for a free evaluation.