i-Solutions provides Impact Services in the following areas of Research and Development.
Mergers and Acquisitions. With our subject matter expertise and extensive due diligence management experience, i-Solutions can ensure that post-merger and integration goals in all business areas are met or exceeded. Refined schedule templates and standardized reports form the basis for customized plans applied across all affected organizations. These plans allow visibility of schedule performance to date as well as forecasts of upcoming activities and progress, so that Management is able to make course corrections before delays occur. Our expertise and associated tools have been proven to be effective for mergers, acquisitions and integrations ranging from stand-alone sites to international multi-site organizations.
Transition and Integration. Experienced in the management of political, labor and societal issues, i-Solutions experts are proficient in the planning and transition of R&D Organizations between companies. With extensive hands-on experience in the integration of R&D activities into new companies and in establishing new organizational priorities, our professionals understand how to redefine market offerings, streamline organizational focus, establish talent management functions, define new KPI’s, improve marketing materials, and lead cultural change.
New Product Introduction. We assist senior management in the acceleration of new product development rather than new product concepts. Our NPI tool provides the ability to effectively manage the multitude of handoffs between various internal and external organizations. It covers major aspects of the activities performed by the R&D organization and identifies early coordination points between Manufacturing, Supply, and Commercial groups early in development. The result is the timely availability of pertinent information needed to make key management decisions.
Lab Operations. i-Solutions professionals are highly capable in the assessment of critical elements associated with Laboratory functionality. These elements include lean work flow, the management of raw materials and supplies through to finished product samples, associated volumes, actual times to conduct analyses and investigations, as well as the estimated number of FTEs to meet the demands within the required time frames.
Product Transfer. Experienced in the transfer of products — in all dosage forms, from clinical supply sites through scale-up to commercial supply sites — our professionals are experts in the effective management of these activities, which are key to preventing Launch delays. i-Solutions has been instrumental in implementation of multiple pharmaceutical Product Transfer programs involving hundreds of products, tens of thousands of finished packs, and hundreds of regulatory markets. Product Transfer — unlike Technical Transfer — is the transition of product supply responsibility from the current source to the future source. Product Transfers executed in compliance with current Quality and Regulatory procedures and policies are enormous and complicated tasks. i-Solutions’ practical knowledge includes elements such as sourcing design, discontinuation, divestment, formula and pack rationalization, site readiness, regulatory, logistics, artwork, and stock build.
Performance Improvement. Using proven Performance Improvement principles, i-Solutions is highly capable in conducting analysis of site Organization Structures, leading Operational Workshops, configuring and applying effective and standardized Reporting Templates, and performing detailed and precise Financial Modeling. Presentations, board papers, workshop reports, budgets for implementation plans and schedules, and financial metrics are some of the deliverables of the analyses. The unique strength of our tools and processes is the full engagement of site staff in the development of the recommended solutions. For this reason, the solutions not only meet the established goals, but are also politically neutral.
Program / Project Management. The professionals of i-Solutions have over 15 years of experience dedicated to the successful management of a range of challenging activities — ranging from small projects through enormous programs — for the Life Sciences industry. Our experience of ‘On Time, On Budget, On Plan’ delivery is supported by the proven methodologies and tools that we provide, which enables Faster Start-up, Lower Costs, and Accelerated Delivery.
Benchmarking. Our experts understand the value of applying well-defined benchmarking information in setting project and program goals and defining success. i-Solutions professionals know how to avoid reinventing the wheel, frequently using commercially available information and tailoring our client’s data to ensure a comparable set of results.
• R&D and Manufacturing Capacity Planning
• Performance Improvements and Financial Modeling
• Lab Analysis