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Regulatory Strategy and Compliance

Regulatory strategy and compliance can be viewed as a burden to speed for some consumer products companies. What many organizations fail to realize is the value that a practical and scalable regulatory approach can deliver.

The number of class-action lawsuits against consumer products companies for alleged poor labeling and marketing practices continues to rise.

With so much uncertainty around marketing claims, the consumer products industry faces insecurity in their regulatory strategy, particularly around labeling. Should the industry wait for FDA guidance to update their guidelines or do they move ahead assuming the current political landscape is likely to reduce government oversight? Mistakes in regulatory strategy or compliance are so costly to consumer products companies in lawsuits and settlements, packaging and labeling rework, excess inventory, and loss of consumer goodwill.


There is no successful one-size-fits-all regulatory strategy – it’s important that it works for your risk profile and business model. An effective strategy for compliance requires careful consideration of your specific needs, long- and short-term business objectives, resources, and culture.

Regularly re-evaluating your long-term regulatory strategy, particularly as you enter into new product and geographic markets will accelerate time to market and minimize business risk.

  • Regulatory Strategy Review and Risk Assessment
  • New Product & New Market Industry Benchmarks and Trends
  • Best Practices Assessment Roadmap Development

Understanding the cross-functional impact of the regulatory strategy improves speed and agility, minimizes re-work, and expedites product launches.

  • Planning and Ownership
  • Process Deployment Plans and Coordination
  • Project and Change Management

The success of your regulatory management process is reliant on a solid foundation of resources and data, with a plan for leveraging and integrating business technology.

  • Resource Requirements
  • Data Needs and Guidelines
  • Implementation Plan & Execution

What Our Clients Say

VP Quality Assurance

Consumer Products Company

Clarkston’s consultants knew the best ways to attack the problem, clearly described the process, respected timelines and were diligent to completion.

We’ve worked with consumer products companies to institute regulatory strategies that build organizations and implement processes and systems to meet regulatory requirements and enable growth into new markets. Contact Steve Rosenstock, our consumer products regulatory strategy expert for more information.

Contact Steve

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