|
|
|
 LabelSuite™
The SPL Label Management Challenge
Are you aware?
Are you prepared?
|
• |
Do you
understand the ongoing
SPL submission process? |
|
• |
Are you
aware of FDA changes
to your labels? |
|
• |
Are there too many label versions /
formats to manage? |
|
• |
Do you have
problems with label
Life Cycle Management? |
| |
|
|
There is a solution available! Reed Technology, a
leading supplier of
Structured Product Labeling (SPL) conversion
services
provides LabelSuite™, a Content of Labeling
management service. Reed Tech delivers solid answers
to the many questions revolving around label life
cycle management. LabelSuite services are designed
to assist you: from authoring and conversion,
through SPL submission, FDA review/approval, to the
synchronization of your internal “label master” for
ongoing maintenance and downstream use (e.g.,
Package Inserts, Final Package Labeling and other
manufacturing processes).
|
|
|
LabelSuite Benefits |
|
• |
Decrease internal workload by
partnering with an experienced
supplier providing complete label
life cycle management |
|
• |
Better manage all label content
(versions, formats, metadata, etc.)
including “child” label submissions,
e.g., Annual Reports, Supplements,
etc. |
|
• |
Eliminate label errors by
confidently submitting validated SPL
packages that were accurately
converted and adhere to the latest
FDA guidelines |
|
• |
Save time and resources by
outsourcing the creation of
Highlights Information and keeping
current on numerous FDA SPL
guideline updates |
|
• |
Quickly respond
to NLM DailyMed SPL postings and
accurately synchronize your internal
label content |
|
|
| |
|
|
|
Critical SPL
Maintenance Note
The FDA has publicly
stated that changes should be expected to a
submitted SPL. Both innovator and generic
manufacturers need to monitor the NLM
DailyMed SPL postings to: 1) verify both
“visible” narrative content and “invisible”
metadata content and 2) harmonize all
content for future submissions, i.e. assure
that the corporate “label master” is fully
in sync with the FDA version for downstream
processes. Additionally generic
manufacturers in “reactive mode” need to
start their internal labeling activity based
on the RLD posting. If in “proactive mode,”
the generic manufacturer must examine the
RLD to see if their prior submitted label
needs to change.
LabelSuite solves
these maintenance problems!
|
|
Content of Labeling Life Cycle
|
LabelPrep™
Harmonizes your diverse labeling
versions, formats and styles into
your corporate standard. Our Label
Metadata Form is used to
record/manage all Drug Listing and
labeling metadata. |
|
|
LabelConsult™
Provides consulting services to
author/verify
SPL-PLR Full
Prescribing Information (FPI) and
Highlights (HL). It can also be used
to review/verify FDA Indexing
applied to SPLs. A detailed,
technical summary can be provided
for inclusion in your FDA
communication to facilitate the
review process. |
|
|
LabelConvert™
Accurately transfers your internal
“label master” (from any format) and
metadata to validated SPL or SPL-PLR.
Our Document Conversion Report
resolves conversion issues and
guarantees SPL quality and
completeness. Delivered SPL Packages
are ready for FDA submission. SPL
exports to Word are available for
FDA negotiation. See
the
SPL-PLR
Conversion Services page for
more information. |
|
|
|
LabelSentinel™ &
LabelCompare™
LabelSentinel provides
you with critical notification via
email of NLM DailyMed SPL and/or
Drugs@FDA PDF postings.
LabelCompare
automatically downloads the SPL
and/or PDF and analyzes differences
between submitted and published
content. You accept or resolve the
differences; we then convert the
approved content into your internal
label master format for ongoing
submissions and downstream use. |
|
|
LabelManage™
Provides content management of
submission related documents, e.g.
drafts, submissions, supplements,
annual reports, CBEs, published
versions, internal master, etc.
These documents are reported by
product family, submission/file
type, version, status, due date and
other metadata. |
|
|
LabelSupport™
Is provided by our expert Help Desk
to assist you in applying current
FDA rules and guidance to the
complete labeling process. |
|
|
|
ISO Certified
- Utilizing ISO
9001:2000-certified processes, Reed
Tech optimizes the balance between
automation and human
expertise
to ensure the highest degree of
conversion and content management
quality and efficiency. |
|
Contact Reed Tech for more information
Please
contact Ben McGinty, for more information about LabelSuite
content of labeling life cycle management
services
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
|
|
|
|
|
|
|
Reed Technology and Information Services Inc. (Reed
Tech), based in Horsham, PA, is a leader in data capture, conversion and management. Reed
Tech is a member of the
LexisNexis Group headquartered in New York, NY, a leading global provider of comprehensive and authoritative legal, news and business information and tailored applications.
©
Reed Technology and Information Services Inc. All Rights Reserved. |
|
|
 |
