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Regulatory & Quality

Professional project management is imperative to operating successfully in highly regulated industries such as Consumer Products and Life Sciences. Project management not only prepares companies to meet regulatory requirements, but is crucial during times of crisis, such as product recalls.

Integrated Project Management Company, Inc. (IPM) helps ensure high quality and regulatory compliance by translating, planning, and executing strategies to achieve successful submissions, ensure agency compliance, and remediate identified issues. We shine when timelines are tight, resources are thin, and quality cannot be compromised. We help clients meet the challenges of changing regulations, such as the serialization of pharmaceutical products and their supply chains.

IPM has years of experience applying professional project management in regulatory and quality organizations and has successfully helped clients address U.S. and global regulatory requirements. Learn how IPM can support you.

Industries we serve

  • Consumer Products

  • Life Sciences

Featured Articles

Steps to Accelerate Successful EU MDR Compliance

Medical device manufacturers have just over six months to be compliant with the new European Union Medical Device Regulation (EU MDR). Yet according to a…

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IPM Increases Investment in Centers of Excellence to Advance Program and Project Leadership and Execution Excellence

Integrated Project Management Company, Inc. (IPM) has expanded its Centers of Excellence (CoEs) to help organizations address specific business challenges and successfully execute on their…

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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…

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Common Regulatory Submission Pitfalls and Ways to Avoid Them

By Susan Carino, Principal Consultant, and Ruba Hadidi, Project Management Consultant Integrated Project Management Company, Inc. (IPM) No matter your company size or phase of…

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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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Using CAPA to Comply with FSMA Can Improve Safety + Profits

The implementation of the Food Safety Modernization Act of 2011 (FSMA) has forced food and beverage manufacturers to face some of the most sweeping safety…

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Prescription for Product Safety

Filling Dangerous Cracks in the Pharmaceutical Supply Chain By Reginaldo Montague, CFPIM, CSCPDownload PDF Prescription for Product Safety APICS magazine (September/October 2016) With 80 percent…

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Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…

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Preparing for the Food Safety Modernization Act (FSMA)

Compliance requirements for the Food Safety Modernization Act (FSMA) are a concern for food and beverage companies of all sizes. Even after compliance, companies must…

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