PIM Submission Preparation
and Life Cycle Management

Reed Technology offers a wide range of services throughout the PIM process: Product Information Harmonisation, 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 Harmonisation

This preliminary step is a comprehensive evaluation of your Product Information that harmonises 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. SmPC vs. SmPC, PL vs. PL, etc.) and delivers a detailed Comparison Analysis Report. Reed Tech then applies your desired changes to create harmonised Product Information that facilitates PIM template creation, improves language translation reuse, and minimises 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 analyses 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 using our software and the EMA PDVE. During the review process, Reed Tech applies EMA requested changes that you approve, as well as any additional changes that you request, until final positive EMA 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 computer-aided translation 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 (variations, etc.) to the PIM document through the life of the product.

Reed Tech Experience

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 our 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