Services for the Life Sciences Industry
Life Sciences manufacturers have many
needs and requirements when it comes to the conversion
and management of their important information and
documents. There are specific regulations that guide
them in how to present, manage and store information for
regulatory submission, yet the implementation of these
guidelines needs to fit with their individual business
requirements.
Reed Tech provides many solutions to fit your firm’s
information and document needs, from Structured Product
Labeling (SPL) & electronic Drug Registration and Listing (eDRL), Physicians Labeling Rule (PLR) and Product Information Management (PIM) conversions to LabelSuite™ Content Management Solutions, PLR
consulting services, Electronic Submissions Gateway (ESG) services, and XML publishing services, all designed to further enhance
the value of your data to your business.
Partnering now and in the future
Working with our customers, we prepare
content and submissions to comply with the changing
FDA regulatory landscape.
For example: the path of SPL compliance extends over time:
| The SPL Roadmap |
 |
Understanding the Regulations and the Industry
We are well versed in the current
regulations and guidance of the U.S. Food and Drug
Administration (FDA) regarding SPL and the European Medicines Agency (EMA) regarding PIM―that impact
your regulatory submissions and other information
needs. Additionally, we stay abreast of these
regulations as they frequently change, thus assuring
you that your conversions will always be up-to-date.
Our clients have chosen Reed Tech
because of our knowledge and expertise. Our
attention to quality and customer service are the
hallmarks of our relationships with our clients. We
have the experience, the capacity, the technology
and dedication to deliver quality results, all at
competitive prices.
We are not done until you are!
Reed Tech ensures compliance for our
customers by providing them with the
capability and
support needed to see each label through to
acceptance. For example, for
all of our SPL conversion customers, Reed Tech provides:
• |
A warranty on the conversion
accuracy of their labels, ensuring they will
pass FDA review for XML and business rule
validation or we fix it at no additional charge |
| • |
A Data Collection Form to assist in collecting and
organizing a label’s metadata |
| • |
A Document Conversion Report that provides a complete listing and
explanation of all actions we have taken in
processing a label so that the sponsor can
determine final treatment of any data element |
| • |
Secure portal access to
transmit and receive their sensitive data |
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