Labeling & Product Information
Reap Benefits Beyond Compliance, With Pharmaceutical Industry Software
Package inserts, leaflets and labels present a challenge to the pharmaceutical industry, not only because they must be modified for each dosage and form of medication, but also because they must be provided in the native language of the ultimate consumer.
The costs associated with creating product information climb over the marketing life of the drug as new discoveries force multiple rounds of regulatory reviews and approvals. Just one change to the product or related information can require the entire set of documentation to be updated and resubmitted for review.
To speed up the review process, regulatory agencies are beginning to request or, in some cases, mandate that regulatory submissions be provided in XML formats. This creates a whole new set of challenges for pharmaceutical companies that now must adapt their publishing systems to support XML output. Regulatory compliance solutions are necessary to significantly improve the review process.
The Arbortext Dynamic Publishing Solution
PTC's Arbortext Dynamic Publishing software for the Pharmaceutical Industry can help you quickly and easily convert existing product information to XML. Furthermore, with your product information in XML, you can achieve additional benefits throughout your organization, such as:
- Maintain a single source of reusable product information content across the enterprise, helping reduce your risk of non-compliance by ensuring all product material contains the latest approved information
- Automatically publish package inserts, prescribing information, labels, product web sites, and promotional material
- Accelerate time to market and reduce costs through efficiencies in the authoring, review, approval, and publishing processes
Regulatory Compliance
As regulatory agencies turn to XML for electronic submission of label content, PTC can help you convert your Microsoft Word content to XML with regulatory compliance software so that you can immediately comply with Structured Product Labeling (SPL). In addition, with your product information in XML, you will be better prepared for other evolving regulatory standards such as Product Information Management (PIM) being developed by EMEA.
Dynamic publishing capabilities provided by PTC's Arbortext software for Pharmaceutical Manufacturing:
- Convert new and existing labeling content to XML
- Create and maintain narrative content and structured data elements
- Develop a single source
of product information for all product materials
Automate publishing to multiple output formats including regulatory-compliant submissions and PDF for printing and viewing
