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Case Studies

Putting the Pieces in Place to Support IND Submissions — and an IPO

Drug discovery, development, and commercialization is like a puzzle. The end may be easy to visualize, but there are many pieces that need to be…

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News

IPM Regulatory Experts to Present at RAPS Convergence Conference

Integrated Project Management Company, Inc. (IPM) is proud to announce that seven of its pharmaceutical, medical device, and biotech regulatory experts will share their knowledge…

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Articles

Parallel Global Submissions: Navigating the Space Between Submission and Approval

Development of a novel therapeutic takes several years of intense research and detailed planning. Because target populations are likely to be distributed over multiple regions…

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Articles

Alphabet Soup: How GxPs Impact the Quality of a Regulatory Submission

If you are confused by the many acronyms related to regulatory submissions, you are not alone. A variety of data from disparate functions must come…

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Articles

Common Regulatory Submission Pitfalls and Ways to Avoid Them

By Susan Carino, Principal Consultant, and Ruba Hadidi, Project Management Consultant Integrated Project Management Company, Inc. (IPM) No matter your company size or phase of…

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Case Studies

Harmonizing a Global Regulatory Submission Process Post-Merger

Project Background Following the merger of two major pharmaceutical companies, the newly formed (merged) organization quickly recognized that the processes for creating, managing, and archiving…

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