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Regulatory Solutions Highly regulated industries such as pharmaceutical, biotech, medical devices, utilities, and insurance have special information needs. They rely on their information and learning solutions to: Meet regulatory requirements Ensure consistency to meet quality standards Lasselle-Ramsay helps companies infuse their organizations with a keen awareness of regulatory processes. We can implement training programs that educate the entire team regarding the business-critical importance of filing processes, deadlines, and other compliance issues. This helps to ensure that dates are met and that proper documentation is available, avoiding a last-minute paper chase. For manufacturers of pharmaceuticals or medical devices, quality control translates into make-or-break business issues. Lasselle-Ramsay helps companies in these regulated industries achieve consistency in quality control processes. We work with you to develop standards across business practices to ensure that you are in conformity with standards for quality—even as information evolves rapidly. With the rise of global markets comes the need to make filings in multiple geographies, making localization of regulatory processes more and more critical. Lasselle-Ramsay helps biotech and medical devices manufacturers meet these complex regulatory needs by translating and localizing product information along the entire value chain. Medical Devices Making sure that quality information is ready when a product is launched has always presented a challenge. The challenge is even greater for medical device manufacturers, because the information is a critical step in the filing requirements. And the information needed for filing may not map directly to the needs of the various internal and external audiences, such as sales, support, clinical staff, and other end users. At Lasselle-Ramsay we begin with the information requirements of all audiences, including regulatory agencies. We build an information model that addresses the needs of each audience and maps directly to your product development life cycle. The result is that users get the information they need, in the form in which they need it. Lasselle-Ramsay's approach fundamentally transforms the product information process by unifying the islands of information that typically exist in various areas of your organization, such as sales, support, and user assistance. We use appropriate technology to ensure that the right information gets to the right people at the right time. And we apply the latest methodologies to tailor information to the way people work, which pays off in increased process efficiencies, time and cost savings, and improved product utilization and success. Lasselle-Ramsay can work with you to do the following: Create a document and a learning stategy that address the content, the content development process, and the technology used to create, store, and deliver the content and learning Build an information model mapped to your product life cycle and the needs of your audiences Provide a complete information and learning solution, from design and development to deployment and maintenance, including localization Lower information and development costs and shorten time to market through content design and single sourcing Provide innovative approaches to delivering information for clinical and laboratory use and for consumers who may not have access to paper documentation or computer workstations Standards, Processes, and Procedures The goal of regulation is to ensure quality, and quality requires consistency. Organizations achieve consistency by applying standards and best practices that are communicated throughout the enterprise. One of the key tools for communicating these business practices is information and learning solutions that bridge the gap between standards and the people who enact them. Lasselle-Ramsay can work with you to do the following: Research and write business standards, processes, and procedures that capture your best practices Develop an information and learning solution that makes your best practice information available to the right users at the right time Develop templates to ensure that standards follow a consistent format

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