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Reed Technology and Information Services, Inc.

Description: 

               Isn’t it time your information worked for you?

Labeling Submission and Content Life Cycle Management Service Provider
– Reed Tech's pharmaceutical industry document conversion experience includes successful conversion of over 2,000 SPL labels. Our customers range from 6 of the world’s top 10 largest pharmaceutical manufacturers to smaller firms, each with a single label to manage.

Summary of Services – Reed Tech provides solutions to fit your firm’s information and document needs, no matter the size of your business. No job is too large or too small and each is equally important and valued.

•      Conversion and Validation Services for 
          o Structured Product Labeling (SPL) 
          o Physician Labeling Rule (SPL-PLR) 
          o Product Information Management (PIM)

•      PLR Consulting Services for Highlights information

•      Author/Verify Full Prescribing Information (FPI) and Highlights (HL)

•      LabelSuite™, Content of Labeling Management Services: harmonizing diverse label versions; alerts of, and label synchronization with, NLM DailyMed and Drugs@FDA postings; label life cycle management.

•      Scanning 
          o Scanning and clean-up of paper documents to digital information assets 
          o Indexing and Classifying scanned documents with Metadata for truly searchable content 
          o Case Report Forms (CRFs) and other related FDA submission documents 
          o Image Annotation

Affiliations – Health Level 7 (HL7): member of the SPL Technical and Process Teams as well as the Generics, Biologics, OTC and Medical Devices and Veterinary Drugs Interest Group’s (VDIG) Animal Health Sub-Teams; HL7 Regulated Product Submission (RPS) Process Team; Drug Information Association (DIA); Regulatory Affairs Professionals Society (RAPS).

ISO Certified – Reed Tech is an ISO 9001:2000 certified company. Reed Tech optimizes the balance between automation and human expertise to ensure the highest degree of conversion, content management, and scanning quality and efficiency.

Our Guarantee – We’re not done until you are! Your SPL, SPL-PLR and PIM submissions must meet your expectations and fully comply with FDA and EMEA requirements before our job is complete.

About Reed Tech Staff – With over 37 years of experience in document capture, conversion, management, distribution and publication for the U.S. Patent and Trademark Office (USPTO) and other Federal and commercial customers, Reed Tech brings powerful tools, techniques and resources to the pharmaceutical industry.

Services: 

Consulting, Data Management, Data Validation, Database Conversions, Document Management, Electronic Data Capture, Electronic Submissions Preparation, Imaging, Regulatory Document Preparation, Workflow Assessment/Re-engineering

Contact Information: 

Reed Technology and Information Services, Inc.
7 Walnut Grove Drive
Horsham, PA, 19044, USA
Phone : 2154416466
Fax :
Internet : www.reedtech.com
Email : bmcginty@reedtech.com
Contact Person : Ben McGinty