Assisting with the creation and management of FURLS accounts, including user registration and permissions.
Access Troubleshooting
Resolving issues related to account access, including password resets and user access problems.
Initial Registration and Listing
Submission Preparation
Preparing and submitting initial registration and listing applications through FURLS for medical devices, drugs, and other products.
Form Completion
Assisting with the accurate completion of required forms and information for new registrations and listings.
Registration and Listing Updates
Modifications
Handling updates and modifications to existing registrations and listings, including changes to product details, facility information, or business operations.
Renewals
Managing the renewal process for registrations and listings to ensure they remain current and active.
Compliance Assistance
Regulatory Guidance
Providing guidance on compliance with FDA regulations related to registration and listing, including understanding requirements and deadlines.
FURLS Navigation
Assisting with navigating the FURLS interface to ensure accurate and efficient submission of information.
Document Management
Document Preparation
Assisting with the preparation of required documentation for
FURLS submissions, including technical data and supporting materials.
Document Tracking
Tracking and managing the submission status of documents and
applications within FURLS.
Submission Tracking and Status Monitoring
Tracking
Monitoring the status of submissions and registrations through FURLS and providing updates on progress.
Issue Resolution
Addressing any issues or requests for additional information from the FDA related to FURLS submissions.
Regulatory Reporting
Periodic Updates
Assisting with periodic regulatory reporting requirements, including updates to FURLS as required by FDA regulations.
Compliance Reporting
Generating and managing reports related to compliance status and FURLS submissions.
Training and Support
User Training
Providing training for clients on how to use FURLS effectively, including how to submit and manage registrations and listings.
Technical Support
Offering technical support for any issues or difficulties encountered while using the FURLS system.
Pre-Submission Consultation
Pre-Submission Review
Reviewing submissions before they are finalized and submitted through FURLS to ensure accuracy and completeness.
Regulatory Strategy
Advising on the regulatory strategy for FURLS submissions to optimize compliance and efficiency.
Audit and Inspection Preparation
Preparation
Assisting with preparations for FDA audits or inspections related to FURLS submissions, including documentation review and compliance checks.
Documentation Review
Ensuring that all necessary documentation is complete and in order for potential FDA reviews.
Liaison with FDA
Communication
Acting as an intermediary between the client and the FDA to facilitate communication regarding FURLS submissions.
Issue Management
Managing any FDA inquiries or issues related to FURLS submissions and ensuring timely resolution.
Record Keeping
Documentation Storage
Maintaining records of all FURLS submissions, correspondence, and related documentation for future reference and compliance.
Reporting
Generating and maintaining reports on registration and listing activities for internal or regulatory review.
These services are designed to streamline the registration and listing process for clients using the FDA Unified Registration and Listing System, ensuring that their submissions are accurate, compliant, and efficiently managed.
