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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

Preventative

  • 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

Corrective

  • Reduced a pharmaceutical’s quality system backlog of deviations and CAPAs by 77%
  • 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

Featured Articles

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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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.…

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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)…

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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…

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