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Articles

Improve Your Regulatory Submissions by Setting, Tracking, and Using the Right Metrics

There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…

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Blog

Make the Case for Crisis Management Before the Crisis

By Carl Manthe, Director, Integrated Project Management Company, Inc. Most people would agree that it’s better to prevent a crisis than to have to deal…

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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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Case Studies

International Product Launch Defies Challenges

It’s challenging for a consumer products company to launch a product line into a new global market. It’s even more difficult to enter several new…

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Articles

Steps to Accelerate Successful EU MDR Compliance

In March 2023, the European Commission got approval to extend the European Union Medical Device Regulation (EU MDR) deadline, which is a relief for patients…

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News

IPM Increases Investment in Centers of Excellence to Advance Program and Project Leadership and Execution Excellence

Integrated Project Management Company, Inc. (IPM) has expanded its Centers of Excellence (CoEs) to help organizations address specific business challenges and successfully execute on their…

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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

Regulatory Expertise Eases the Way for Company’s First IND Submission

A young biopharmaceutical company developing a pipe-line of preclinical cancer immunotherapy treatments was preparing to file its first investigational new drug (IND) application with the…

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Articles

Using CAPA to Comply with FSMA Can Improve Safety + Profits

The implementation of the Food Safety Modernization Act of 2011 (FSMA) has forced food and beverage manufacturers to face some of the most sweeping safety…

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