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Regulatory & Quality

Professional project management is imperative to operating successfully in highly regulated industries such as Consumer Products and Life Sciences. Project management not only prepares companies to meet regulatory requirements, but is crucial during times of crisis, such as product recalls.

Integrated Project Management Company, Inc. (IPM) helps ensure high quality and regulatory compliance by translating, planning, and executing strategies to achieve successful submissions, ensure agency compliance, and remediate identified issues. We shine when timelines are tight, resources are thin, and quality cannot be compromised. We help clients meet the challenges of changing regulations, such as the serialization of pharmaceutical products and their supply chains.

IPM has years of experience applying professional project management in regulatory and quality organizations and has successfully helped clients address U.S. and global regulatory requirements. Contact us to learn how IPM can support you.

Industries we serve

  • Consumer Products

  • Life Sciences

Featured 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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Make the Case for Crisis Management Before the Crisis

Most people would agree that it’s better to prevent a crisis than to have to deal with one. But the reality is, by their nature,…

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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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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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Steps to Accelerate Successful EU MDR Compliance

This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.  According…

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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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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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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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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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