Quality Information Handling
Quality information handling is vital throughout a drug's lifecycle. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of delayed market approval and non-compliance. Synchrogenix provides distinct market offerings that advance and protect ownership, yet support collaboration through customer engagement and transparency. We've simplified previously complex tasks, making it easier to capture all your important regulatory information in one place.
Synchrogenix's GlobalSubmit Regulatory Information Management (RIM) System
Independent, Yet Integrated Products for Your Most Important Data
Synchrogenix's GlobalSubmit RIM system contains four modules grouped into two products: COMMUNICATE and MANAGE.
GlobalSubmit COMMUNICATE
- A central system to track agency correspondence and commitments.
- Emphasizes the end user experience while capturing the important information departments need to respond to Agency requests and fulfill commitments in a timely manner.
- Allows users to create accurate records of non-submissions information exchanged between sponsor and Agency.
- Takes large amounts of information across many products, and potentially multiple agencies, and distills it down into smart user categories.
- A sensible solution for tracking what commitments were made to various agenices and when those commitments are due.
- Simplifies entering, tracking and meeting commitments on time with complete internal transparency.
- Easily customizable.
GlobalSubmit MANAGE
- A central system to track submissions data and regulatory activity status.
- Gives regulatory operations teams the high-level data needed to manage present and future workloads.
- Provides scalability as your organization develops new products and moves further along the lifecycle of active products.
- Views can be customized to give everyone within a regulatory department only the information relevant to their job role.
- Real-time awareness to the regulatory status of each product in your global portfolio.
- Edit and run reports on historical and upcoming global regulatory activities filtered by region, product, time increment, etc. with just a few mouse clicks.
RIM for Medical Devices and Diagnostics Companies
Medical devices and diagnostics companies are competing in a complex regulatory environment. Demands for regulatory and compliance information needed to support 510(k), PMA, De Novo and HDE submissions continue to increase. GlobalSubmit RIM also provides medical devices and diagnostics companies with web-based, cloud-hosted applications for managing product registration, commitments and regulatory submissions. This centralized and single source system provides a global user base with real-time information needed to ensure product and registration quality.
RIM System Features
- Anytime, anywhere access with Secure CLOUD
- Organize worldwide portfolio and health agency correspondence by product family, products, applications and regions
- Vital real-time reporting and status updates
- Global Submission Support
