Contact Us

IPM Insights

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…

Read More

Articles

Disruptive Events: How Medical Device Companies Can Deal with Them Head on and Learn for the Future

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

Articles

Compliance Issues? First, Don’t Panic

Abstract: Meeting compliance issues is like preparing for a hurricane: both situations require making sure that everything is nailed down well before the storm hits.…

Read More

Case Studies

Successful Medical Device Design Transfer Lifts One of the Largest FDA Mandates in History

Project Background A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000)…

Read More

Case Studies

Coordination Secures On-Time Biopharmaceutical NDA Submission and Launch

Project Background A major pharmaceutical company in-licensed a developmental pharmaceutical product nearing the end of Phase III clinical trials. At the time, the previous owner…

Read More