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Regulatory and Quality

Prepare thoroughly. React quickly. Advance confidently. Access the expertise you need to navigate submissions and compliance standards in highly regulated markets.

In highly regulated markets, success requires a disciplined approach and experience navigating complex requirements and standards. IPM has the expertise to help you achieve successful regulatory submissions, adhere to changing compliance regulations, and address quality concerns to quickly get your product to the customers who need them.

Getting your products to the people who need them and ensuring they’re safe and high-quality are noble goals. In a highly regulated industry, it can be challenging to reach those goals. You need to involve multiple functions and both internal and external stakeholders. At the same time, regulations continue to evolve, and it’s hard to keep up.

IPM’s disciplined approach and experience can help you achieve on-time regulatory submissions, adhere to compliance regulations, and address identified quality issues. Whether your company is inexperienced or simply overtaxed, our regulatory and quality experts can lead your efforts to:

  • Meet your submission goals
  • Align your regulatory strategy to your organization’s strategy
  • Streamline processes and improve governance and structure
  • Minimize agency questions and concerns
  • Get to market faster
  • Prevent warning letters, consent decrees, recalls, and other compliance problems
  • Address crises quickly, with minimum disruption to operations

Keeping ahead of constantly evolving regulations in the U.S. and around the world is overwhelming without dedicated resources. Using our program leadership, stakeholder management skills, and regulatory insights, we’ll develop an efficient strategy for successful regulatory submissions. When directives, regulations, or standards change, we’ll be there to help you manage your compliance program and identify any gaps. And IPM can help you respond to an FDA warning letter, consent decree, or product recall.

With proven processes and deep experience, IPM can help you navigate your specific regulatory and quality needs.

Project Leadership Pairing project management discipline with regulatory and quality experience, IPM leads your team through the work necessary for timely regulatory submissions and quality compliance.
Regulatory Submissions Count on IPM’s regulatory experts to lead cross-functional projects to fully complete submissions on schedule and meet your organization’s strategic goals as well as your customers’ needs.

Testimonials

IPM has two attributes that differentiate them: the first is true commitment to client success; the second is their proactive approach to leveraging the collective talent of IPM. Their commitment to client success was exemplified by the time invested in getting to know not just my team but also our interfaces and stakeholders. When it comes to the breadth of IPM expertise, I was impressed by their rapid and effective engagement of experts from the Centers of Excellence, which facilitated delivery of solutions that met the breadth of our needs."

Vice President, Global Quality Analytical Science & Technology, who has engaged IPM at two top-tier biopharmaceutical companies

We were aware that if we hired an IPM project manager, there would be a whole system of knowledge behind that person that would really help us as we were going through new transitions for our company—preparing for NDA, preparing for commercial—and help us better anticipate what would be ahead of us and plan for that."

Ericka Benson, VP, Portfolio and Program Management, Catabasis Pharmaceuticals Inc.

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Our Regulatory and Quality Center of Excellence

Kristin Kinscherff

Senior Director

Stacy Townsend

Director

McKenzie Wesson

Director

Susan Carino

Principal Consultant

Tahir Hashmi

Senior Project Management Consultant

Troy Kinney

Senior Project Management Consultant

Justin Holtgrave

Senior Project Management Consultant

Rani Maloney

Project Management Consultant

Charles Murphy

Project Management Consultant

Mike O’Neill

Project Management Consultant

Greg Palagi

Project Management Consultant

Lalitha Sista

Project Management Consultant

Rachell Foreman

Project Management Consultant

Learn More About Our People

Reach out to discuss your specific regulatory and quality needs.