Health & Pharmaceutical
Specialized Data and Content Transforms That Ensure Regulatory Compliance Success
Customized Solutions for Complex Digital Content Challenges
DCL provides expert conversion services to the health and pharmaceuticals industries. With subject matter expertise in Structured Product Labeling (SPL), standard response packages, research manuscripts, publications, reference materials, electronic medical records, and more, DCL ensures content and data comply with federal regulations. We work with organizations from biotech firms, medical equipment manufacturers, pharma, veterinary medicine, to hospitals and medical records industries.
DCL is a member of the SPL Working Group and created most SPL Working Group data samples. DCL is proud of its completed and successful pilot programs for many Fortune 100 pharmaceutical companies.
Services and Solutions
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Compliance and Regulatory: Structured Product Labeling (SPL) and ACA6004.
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Electronic Medical Records (EMR): Involvement with an HL7 initiative for the automation of medical records of which the SPL initiative is one of the earlier regulatory efforts.
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Medical Literature: Documents and research manuscripts for publication and for online databases, for corporate use, for STM publishing, and for governmental agencies, including NIH.
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XML and PDF databases: Processing of documents, policy manuals, research documents, and more.
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CASE STUDY
DIGITAL TRANSFORMATION
FOR PATIENT INFORMATION LEAFLETS
A multinational pharmaceutical health care organization wanted to replace the print-based leaflet distributed in its drug packaging with a link to a digital version...
BLOG POST
WHAT IS GDUFA?
The Generic Drug User Fee Act (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry.
Source Formats
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Hardcopy Documents
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Electronic Medical Records
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Policies and Procedures
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Training Materials
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Regulatory Filings
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PDFs
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Spreadsheets
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Microfilm & Microfiche
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Audio
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Video
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Unstructured Data
Target Formats
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XML
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ACA6004
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SPL XML
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HL7
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Custom Data Feeds
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NISO STS
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EPUB/MOBI
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JSON
INDUSTRY INVOLVEMENT
SPL Working Group
DCL has been a huge help regarding the FDA registration process. They have registered many of my products with the FDA, as well as, my customers NDC numbers and registrations. Their team is very helpful and answers all of my questions. They get back to me quickly and process through the FDA very quick as well. When there is a question regarding an email they reach out directly for more clarity. I have had no issues with DCL and highly recommend.