Many organizations are stepping up to innovate and transform their operations to implement goods and services needed in the battle against COVID-19. Reed Tech stands ready to help and is making mitigation of COVID-19 a priority. We remain fully operational to assist with US FDA compliance requirements. In this uncertain time, we are available to help existing customers and first-time entrants with expedited services in regards to COVID-19 related activities. Depending on the activity, the compliance requirements may require experienced guidance.
In the area of related products that help mitigate or treat COVID-19 in the pharmaceutical sector, Reed Tech performs conversion and submission services available for:
- Manufacturers and distributors of drug and biologic products who need to submit regulatory data through FDA eDRL (Electronic Drug Registration & Listing)
- SPL (Structured Product Labeling) process
- Drug Listing for Rx, OTC and Biologic Products
- Content of Labeling Review Submissions
- Labeler Code Request/Registration
- Establishment Registration
For existing customers, Reed Tech will expedite SPL conversions for COVID-19 related products whenever possible. For new customers, we will provide you guidance on how to submit required SPL documentation to the FDA so you can get your product to market as quickly as possible.
To qualify for these compliance services, contact: [email protected]
Drug Label Digital Reference
If analysis is needed to compare your COVID-19 related drug product label to those currently in the market, Reed Tech is extending a limited time free access to qualified drug product label authors. Navigator™ for Drug Labels helps pharmaceutical regulatory researchers ensure accurate and up-to-date drug label content. With Navigator, you can quickly and easily access the entire set of FDA-approved prescription, over-the-counter (OTC) and homeopathic drug product labels.
- Develop label strategy and get to market faster with intuitive single word search
- Conduct side-by-side label comparisons of up to five labels
- Analyze similar products or previous label versions and discover acceptable usage changes
To qualify for the limited time free access to Navigator for Drug Labels, contact: [email protected]
To qualify for this two-week free trial, you must be a new contact who will be using Navigator for Drug Labels to research products that could combat COVID-19. Trial starts upon your qualification and user must agree to our terms and conditions.
For innovators and new entrants into the medical device sector, US FDA regulatory compliance requires experience. Reed Tech provides guidance for device labelers that need to build and submit regulatory requirements concerning UDI (unique device identification) to the FDA in Structured Product Labeling (SPL) format.
Reed Tech is committed to helping those who are trying to make a difference during the pandemic. If you have a medical device that is being developed to treat COVID-19 disease, contact us about US FDA regulatory submission solutions: [email protected].
Medical Device Quality, Safety and Regulatory Data
If you are researching 510(k)s in order to bring a COVID-19 related medical device to market, Reed Tech Navigator™ for Medical Devices helps you quickly find relevant predicates to streamline your application. Search 510(k)s, biologic and De Novo PDFs (+66k) by intended use, indications for use and device description.
- Find the best predicates to expedite 510(k) applications
- Find predicate and successor devices for risk management and post-market surveillance
- Analyze safety and quality profiles to identify product liabilities
- FDA guidance related to COVID-19 are accessible in Navigator including those related to face masks, respirators, ventilators and other non-invasive remote monitoring devices
For researchers of medical device FDA regulatory data, Navigator may yield the quick results you need. To qualify for COVID-19 related *limited time free access to Navigator for Medical Devices, contact: [email protected]
To qualify for this two-week free trial, you must be a new contact who will be using Navigator for Medical Devices to research medical devices that could combat COVID-19. Trial starts upon your qualification and user must agree to terms and conditions for the trial.