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Consumer Products

Life Sciences

Quality & Regulatory Consulting

CONSUMER PRODUCTS

Regulatory Strategy and Compliance

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

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Data Quality

Consumer products companies rely on the quality of their data to make strategic business decisions, but quality data is also critical for regulatory compliance. Regulations are continually evolving to reflect new information, and companies must be able to comply with data and records requirements.

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Validation Strategy and Services

Integrating systems and process validation into your business may seem daunting, but our risk based approach helps you meet global needs without being overly cumbersome.

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Quality & Regulatory Consulting

LIFE SCIENCES

Regulatory Strategy and Compliance

Regulatory strategy and compliance – it sounds fairly straightforward. What most organizations fail to realize is the untapped potential for strategic value that a pragmatic and scalable approach to compliance can deliver.

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Quality Processes and Systems

Where quality operations may be a cost center for some, truly evolved life sciences organizations know that a proactive approach to quality yields far more than a passing grade – it propels your whole business forward.

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Remediation Services

Our approach to remediation quickly identifies the cause and subsequent solution to gaps in your compliance position. We are unwaveringly focused on enabling your business to do what it does best – delivering safe and effective treatments to your patients.

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Validation Strategy and Services

The life sciences industry lives and breathes innovation – nearly every company is looking for the next big thing. But all the breakthrough drug discoveries and technological leaps forward mean little without a validation strategy that guarantees a replicable level of quality and efficacy.

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Data Integrity

At some point, maintaining data integrity was as simple as ALCOA. But, as we continue to collect and store data at a nearly exponential rate, it’s not something that an acronym alone can solve anymore.

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Quality and Regulatory Post-Merger Integration

As organizations embrace M&A as a tool for growing business and expanding therapeutic offerings, the ability to successfully, efficiently, and quickly align compliance functions as a new enterprise becomes a substantial competitive advantage.

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Quality & Regulatory Experts

Janel Firestein

Partner, Life Sciences Industry Leader
Janel is a recognized expert delivering business results in the areas of regulatory compliance, business process improvement, change management, product development, quality systems, and strategy.

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Mike Leary

Partner
Mike has led global initiatives for companies that have included quality systems and ERP implementations, organizational design, and regulatory remediation and compliance initiatives.

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Irene Birbeck Lewis

Associate Partner
Irene specializes in the management of quality systems process and technology implementations within the life sciences, with specific experience in the chemical, pharmaceutical, and biotechnology industries.

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Related Insights

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Preparing Quality Data for Acquisition

Merger and acquisition failure rates continue to rise due to extenuating and spiraling costs post-merger. Misaligned cultures, technologies, and processes ...

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Breaking Down the Changes to 510(k) Clearance

On November 26, 2018, FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, ...

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Regulatory Implications of AI Toys

The growth of Internet of Things (IoT) isn’t limited to self-driving cars and home security systems. AI toys can already ...

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Phone: (919) 484-4400
Email: info@clarkstonconsulting.com