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PIM Submission
Preparation
and Life Cycle Management
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Start your PIM submissions now and gain valuable
experience |
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Convert your new and post-authorization
PI to PIM |
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Use our industry leading subject matter
expertise to create
validated PIM submissions |
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Leverage our significant SPL conversion
experience with over
80 pharmaceutical manufacturers |
Reed Technology offers a wide range
of services throughout the PIM process: Product
Information Harmonization, PIM Creation (English and
other languages), Translation Services, and PIM Life
Cycle Management. Our services are tailored to meet your
specific needs. We can provide you the full range of PIM
services or an “a la carte” approach that allows you to
utilize the resources you need, when and where
necessary, during any phase of the PIM life cycle.
Product Information Harmonization
This preliminary step is a
comprehensive evaluation of Product Information that
harmonizes the content prior to migrating it into the
PIM format. Reed Tech uses automated tools, augmented
with human expertise, to perform a
character-by-character comparison between like documents
(e.g. SPC vs. SPC, PL vs. PL, etc.) and delivers a
detailed Comparison Analysis Report. Reed Tech then
applies your desired changes to create harmonized
Product Information that facilitates PIM template
creation, assists in language translation reuse, and
minimizes content discrepancy risks. Document comparison
services can also be applied to post-authorised,
translated components.
PIM (en) Creation and Updates
This service creates the PIM
(English) instance from QRD templates in any file format
and supports updates during the pre-opinion phase. Reed
Tech analyzes the PI documents, identifies reusable
text, and creates the PIM instance per your specific
business rules. To ensure accuracy, quality control is
performed on the PIM document using automated tools and
proofing specialists and is then validated against the
latest DES. During the review process, Reed Tech applies
EMEA requested changes that you approve, as well as any
additional changes that you request, until final
positive EMEA opinion.
Translation Services
Translation services are provided
for all PIM supported languages or just your selected
languages. Translations are performed by experienced
human translators, knowledgeable in pharmaceutical
content, supported with state-of-the-art tools. Our
language translation service can provide full
translation capabilities or complement your existing
translation capabilities to create the full collection
of language content for inclusion into the PIM document.
PIM (all) Creation and Updates
During the post-opinion phase, Reed
Tech integrates all translated language content into PIM
and creates the PIM (all languages) instance for review.
The full proofing and validation processes discussed
above are applied. During the review process, Reed Tech
applies Member State-requested language changes that you
approve, as well as any additional changes that you
request, until EC approval.
PIM Life Cycle Management
Reed Tech's PIM Life Cycle
Management service provides ongoing project management
for the PIM life cycle. This service incorporates and
supports all ongoing changes to the PIM document through
the life of the product.
PIM Preparation & Life Cycle
Management
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DES – Data Exchange Standard |
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DTD – Document Type
Definition |
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EC – European Commission |
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EMEA – European Agency for the Evaluation of
Medicinal Products |
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PI – Product Information |
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PIM – Product Information Management |
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PL – Package Leaflet |
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QRD – Quality Review of Documents |
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SPC – Summary of Product Characteristics |
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SPL – Structured Product Labeling |
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Reed Tech Experience
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In-depth knowledge of EMEA PIM Specifications |
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Full PIM service methodology
including workflow |
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Successful completion of multiple PIM
conversions with various languages |
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Over 80 pharmaceutical manufacturer clients,
including 6 of the 10 largest
in the world |
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Excellent customer relationships in the course
of successfully converting over 2,000 SPL
documents |
Reed Tech optimizes the balance
between automation and human expertise to ensure the
highest degree of service quality and efficiency.
Because of our unique range of services and tools, Reed
Tech has the flexibility, strength and experience to
offer you the optimum PIM solution for your business
needs—now and in the future.
Contact Reed Tech for more information
Please
contact Ben McGinty, for more information about PIM Conversion
services
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
+1-215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
+1-215-441-6400
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