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Services for the Pharmaceutical Industry
Pharmaceutical 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),
Physician Labeling Rule (PLR) and
Product Information Management (PIM)
conversions to
the
LabelSuite™
Content Management Solutions
and
PLR
consulting 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
regulatory landscape.
For example: the path to SPL compliance with FDA
regulations extends over time:
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The SPL Roadmap |
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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 Agency for the
Evaluation of Medicinal Products (EMEA) 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 Label Metadata 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;
And secure VPN access to
transmit and receive their sensitive data.
Contact Reed Tech for more information
Please
contact Ben McGinty, for more information about conversion and
content management services we provide to the medical
products manufacturers and pharmaceutical firms
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
215-441-6400
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