i-Services text Operations Improvement text --------------------------- One of i-Solutions’ core services focuses specifically on Operations Improvement. Utilizing proprietary software and the expertise of our seasoned professional staff, we can facilitate a faster start-up, lower costs and accelerated benefit delivery. We are able to make this commitment by working closely with your Management Team and your Project Staff as well as bringing tried and proven processes, templates, presentations and methodologies to the project. Click on the items below to discover additional details about each of the areas that you are interested in. Merger/Acquisition/Integration Design Database R&D and Manufacturing Capacity Planning Product Transfer Regulatory Database Performance Improvements and Financial Modeling Lab Analysis i-Product: LAMPS® “We needed someone to gather the facts and make recommendations without any corporate political involvement. We needed the best solution for the company, not for individuals. Not only did i-Solutions (formerly Impact Management Services – IMS) deliver the recommendations based on the facts, but they were able to facilitate the execution as well.” CEO of Merging Companies New Product Introduction text ----------------------------- One of i-Solutions’ core services focuses specifically on New Product Introduction. Utilizing proprietary software and the expertise of our seasoned professional staff, we can facilitate a faster start-up, lower costs and accelerated benefit delivery. We are able to make this commitment by working closely with your Management Team and your Project Staff as well as bringing tried and proven processes, templates, presentations and methodologies to the project. Click on the items below to discover additional details about each of the areas that you are interested in. NPI Module Lab Analysis Regulatory Database Design Database i-Product: IPIT® “i-Solutions (formerly Impact Management Services – IMS) did exactly what they said, exactly on time, and exactly at the quoted price. We could have never accomplished what this program has achieved without them and their expertise.” President of a Global Pharmaceutical Company Regulatory and Compliance text ------------------------------ One of i-Solutions’ core services focuses specifically on Regulatory and Compliance. Utilizing proprietary software and the expertise of our seasoned professional staff, we can facilitate a faster start-up, lower costs and accelerated benefit delivery. We are able to make this commitment by working closely with your Management Team and your Project Staff as well as bringing tried and proven processes, templates, presentations and methodologies to the project. Click on the items below to discover additional details about each of the areas that you are interested in. Observation Index Regulatory Database i-Products: CATS® (Corrective Action Tracking System) IPIT® (Investigational Product Inventory Tracking) “I don’t know where we would be without the program management expertise, processes and the data management tools offered by i-Solutions (formerly Impact Management Services – IMS). We could have never done the project without them.” Executive of a Specialty Consulting Company Regulatory Database text ------------------------ i-Solutions’ Regulatory Database captures the critical items needed to manage Product Transfers through the transitional regulatory stages. It incorporates: the schedule structure based on dose form, strength, pack type and markets regulatory milestones from ‘Regulatory Submission Requirements Defined’ through ‘Receipt of Regulatory Approval’ milestone durations and assigned resources. The application provides progress reports including ‘Planned and Actual Percentage Complete’, overall ‘Project S-Curve’ and ‘Missed Milestone Analysis’ against the baseline schedule. The Regulatory Database provides pertinent information needed by Management to foresee and rectify schedule challenges. “i-Solutions (formerly Impact Management Services – IMS) consultants are some of the most experienced individuals that I have ever worked with. Once they understand the goals, they deliver on time and on the mark in a truly professional manner.” VP of Human Resources of a Large Life Sciences Company Lab Analysis text ----------------- The QC and Planning software application was created to assess the critical elements associated with Lab Analysis functionality. Those elements include analysis of raw materials to finished product samples, associated volumes, actual times to conduct analyses and investigations as well as estimated number of FTEs to meet the demands within the required time frames. The application can import data from related systems (i.e.; TrackWise, LIMS, Stability Database, Spreadsheets) and can calculate required and available resources for specific work volumes and types of laboratory analyses. With this unique tool i-Solutions can provide Management with insight to areas that need attention. “Based on experience and exceptional project execution, i-Solutions has built an invaluable set of world class tools that no one else can offer.” CEO of a Major International Pharmaceutical Company New Product Introduction text ----------------------------- “A cohort of mine recommended i-Solutions (formerly Impact Management Services – IMS) for helping with a really challenging project. The recommendation was well made. They got us out of the corner we were in within budget and on an accelerated time frame.” President of an International Manufacturing Company