A centralized, secure and validated platform for SPL generation, storage and submission management
Reed Tech SingleSource™ for Drug Products manages FDA human prescription, over-the-counter and animal drug product submissions data in Structured Product Labeling (SPL) format
Master Data Management for your drug product, establishment facility and labeler company data along with on-demand SaaS SPL generation for SPL-ER, SPL-LCR and Product Listing Metadata updates without third-party support with fast, accurate submissions to FDA’s Electronic Drug Listing and Registration System (eDRLS)
Secure Regulatory Data Management
Manage product listing, establishment facility, and labeler company data across multiple teams with a secure and validated cloud-based solution
Multi-Function Solution: Data collection/capture/validation, SPL preparation & management helps meet strict FDA guidelines
Leverage a single source of truth for product listing information eliminating time searching databases that may span multiple departments or facilities
Available 24/7 in a Software-as-a-Service model without the need to install or validate software helps lower IT cost and the need for third party support
SingleSource for Drug Products is a web-based application developed to 21 CFR Part 11 compliant standards that allows drug product manufacturers and distributors to collect and store their global product listing, establishment facility, and labeler company data in an easy to use master submission data library. Pharmaceutical companies can eliminate data disparity by leveraging a single source of truth for product listing information and save valuable time searching their internal databases that may span multiple departments or facilities. The application will host all this information in one easily searchable database and help ensure consistent use of data fields throughout all SPL types and versions.
A full-service approach to SPL creation, validation and management that reduces time to submission and improves processes for cross-functional teams
Data validation based on up-to-date FDA business rules and industry controlled vocabularies ensures data accuracy
Standardized SPL conversion request template, allows for quicker order processing and placement into the Reed Tech production process
Ensures consistent usage across all users so teams are not left in the dark
SingleSource for Drug Products is designed for manufacturers and distributors of drug products that want to gain better control and insight into their SPL conversion process. The application provides on-demand HL7 Structured Product Labeling (SPL) format generation for all human prescription, over-the-counter, dietary/herbal medicines and animal drugs, allowing you to meet strict FDA deadlines without requiring third-party support or premium costs. Easy-to-use web-based SPL forms include built-in FDA business rule verification for quick identification and resolution helping to remove ambiguity around the accuracy of your data. Once your data is imported or entered into the system, you can use it many times with peace of mind that your data is accurate and meets FDA requirements.
Transparency of work in progress across your organization helps meet internal and FDA deadlines
Submission support from dedicated Reed Tech Life Sciences staff provides comfort in capturing the proper regulatory requirements
Automated order processing, receipt, review and approval workflow allows you and your team to better plan your next steps
Seasoned submission partner with over a decade of SPL experience, 1,000+ life sciences customers and 47,000+ drug SPLs submitted to FDA
Reed Tech SingleSource provides manufacturers and distributors of drug products with an easy-to-use order processing, receipt, review and approval workflow. The system provides real-time status updates on Content of Labeling conversion work-in-process via the searchable order management dashboard. Manufacturers and distributors are kept up-to-date when an order is placed, confirmed and delivered through an automated email process. Users can also monitor and review SPL activity efficiently with built-in system reporting.
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