Articles
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…
Articles
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…
News
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…
Articles
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…
Articles
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…
Articles
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…
Case Studies
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…
Articles
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.…
Case Studies
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)…
Case Studies
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…