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Regulatory and Quality

Quality and Compliance

Quickly get up to speed on new regulations or address the current gaps that could lead to recalls, warning letters, or other compliance problems that disrupt your operations. 

Overview

When it comes to quality and compliance, there’s no room for error, especially in highly regulated industries such as pharmaceuticals, cell and gene therapy, and medical devices and diagnostics. Vigilance means staying on top of changing regulations and staying prepared for audits and inspections. Addressing gaps that could lead to warning letters, recalls, and lost market share is crucial. IPM will lead you through the steps to prioritize, plan, and accelerate execution of ongoing compliance initiatives or crisis response.  

With a disciplined approach and expertise in product development and project portfolio management, we can help you identify gaps, plan and execute quickly, avoid delays, and meet deadlines.  

Access proven quality and compliance expertise  

Adapting to changing regulations, mitigating quality issues, and navigating the complexities of compliance are essential to your success. IPM is a trusted resource for managing urgent quality and compliance projects as well as improving routine processes.

Best-in-class project management fuels success in product certifications and meeting regulations and standards.  

An IPM consultant will:  

  • Take ownership of quality and compliance activities, organizing the work to ensure minimal disruption to daily operations. 
  • Reduce delays through clear communication, knowledge of requirements, and avoidance of common pitfalls. 
  • Quickly identify gaps and develop a tailored execution roadmap. 
  • Leverage portfolio analysis to prioritize the products for compliance management. 

With IPM’s expertise you can enhance quality and put an end to disruptions due to recalls, changing regulations, or compliance issues. 

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How We Can Help You

Lead urgent quality projects

When your back is against the wall due to a compliance or quality crisis, IPM is ready to step in. IPM consultants will lead remediations after warning letters, consent decrees, or other adverse events. We can help minimize the impact of product recalls and prepare you for plant audits or pre-approval agency inspections. When you are faced with new regulations or compliance mandates, we’ll develop a customized, cross-functional roadmap that ensures deadlines are met. IPM will plan and execute your corrective and preventative actions (CAPA) related to customer complaints, manufacturing problems, or product quality issues. With best-in-class project management skills, we’ll minimize disruption to your operations during the crisis. 

Improve quality and compliance operations

IPM understands how to take quality and compliance efforts to a higher standard. Through a customized, disciplined approach, we guide you in selecting and implementing the processes and technology solutions that best meet your needs, from quality management systems (QMS) to change control processes. Or we can help optimize your existing systems. Improvements in quality and compliance can also come from expanding your team’s project, program, and portfolio management capabilities. Life science companies rely on our expertise in good practice (GxP) compliance to ensure their people, processes, manufacturing facilities, and laboratories meet or exceed agency guidelines. 

Provide project management expertise

Special projects such as a regulatory submission or revised submission, product certification, or label or packaging change can strain resources or require experience you don’t have. With IPM leading the project, you can be confident it will be done right the first time. We have the expertise and track record to be your go-to resource to lead these projects to timely and successful outcomes. We understand how to manage complex programs and coordinate efforts across functions, products, and businesses. 

Count on IPM When You Need Experience in Quality and Compliance

Compliance changes and quality issues don’t have to wreak havoc on your organization. With IPM as a partner, you can move through the challenges and complexities, saving time and money. Our experience is the difference. Over the past 12 years, we’ve worked on scores of regulatory, quality, and compliance projects for dozens of companies.  

IPM consultants hold the technical, regulatory, business, and scientific credentials to help you navigate quality and compliance issues and ready your organization for a new era focused on growth and opportunity. Our disciplined approach and specialized expertise will give your company an edge in managing quality and compliance for greater market success. 

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Our Experts

McKenzie Wessen IPM Director

McKenzie Wessen

Director

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Interested in learning how we can help with your quality and compliance?

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