Contact Us

Regulatory & Quality - Life Sciences

All sectors of the life sciences industry—biotechnology, pharmaceuticals, medical devices, and diagnostics—are highly regulated.

Whether you are developing products or already manufacturing them, Integrated Project Management Company, Inc. (IPM) ensures that your organization considers and is compliant with applicable regulatory standards and requirements. Our well-versed project management consultants work onsite to help teams anticipate and mitigate problems before they happen, and resolve issues through careful planning, execution, and effective decision-making.


IPM sees regulatory and quality projects for Life Sciences through two lenses—prevention and correction. Our services apply in the following areas:

Preventive Services

  • Process development and optimization
  • Product development
  • Design control
  • Quality system
  • GMP, GCP, GLP, ISO standards
  • Validation
  • CAPA​
  • European Union Medical Device Regulation (EU MDR) compliance
  • U.S. and global regulatory submission coordination
  • Pharmacovigilance risk audit preparation
  • Inspection readiness
  • Quality audit preparation

Corrective Services

  • Audit and compliance remediation
  • Recall execution
  • Warning letter response
  • Consent decree coordination

Our Results


  • Planned and executed pharmaceutical quality audit preparation, resulting in zero defects
  • Led implementation and consolidation of numerous Regulatory Affairs (RA) information systems while serving as virtual Project Management Office (PMO)
  • Improved CAPA handling processes to reduce compliance risk for major device manufacturer
  • Reengineered Quality Affairs (QA) release process for pharmaceutical alliance, cutting quarantine hold time in half
  • Optimized regulatory submissions and documented management processes
  • Harmonized post-merger QA lab practices for drug giant
  • Conducted process mapping workshops to save imperiled ISO certification


  • Reduced a pharmaceutical’s quality system backlog of deviations and CAPAs by 77 percent
  • Coordinated 23 drug manufacturing site upgrades to lift FDA warning letter
  • Led medical device design transfer to lift one of the largest FDA mandates in history
  • Oversaw the integrity of FDA audit responses for manufacturing, field data, and design deficiencies
  • Managed large cross-functional effort to successfully lift FDA device recall

Contact us about your project.

Featured 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 Article

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 Article

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 Article

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…

Read Article

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 Article

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 Article

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 Article

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 Article

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 Article