Managing the Complexity of the Risk-Based Regulatory RoadMap

Global Medical Devices, IVD, CDx, Bio Sensor Diagnostics, Biomarkers SaMD, Drug-Device Combinations, Drug Delivery, and Regulatory Compliance

Hands-On Seamless Product Development, Regulatory and Clinical Trial Strategies

Benefits of Choosing Us

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Program Management Center of Excellence

Cost-effective, functional management "Concept through Commercialization".

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Product Life Cycle Management and Compliance Services

Hands on value added short term SME support including medical writing.

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Financial Success

Building the Value Proposition and due diligence for senior management and investors.

Helping You Drive Certainty and Success

624Advisors is your partner for speed-to-market success. We can help you navigate the regulatory landscape with confidence by creating a clear, tailored Regulatory RoadMap and developing a robust, Risk-Based Value Proposition that drives certainty and success.

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Our Mission

Based on our 35 years of expertise and experience, we have a deep appreciation of the journey from concept to commercialization, bringing best strategies for speed to market. We recognize the critical need for a creative sound regulatory and clinical strategy as well as adherence to Product Life Cycle compliance requirements that result in ultimately becoming the Standard of Care. This expertise in product development strategies positions us to create a comprehensive regulatory/clinical roadmap and develop a Risk-Based Value Proposition that delivers certainty for both regulatory compliance and financial success.

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Get in Touch

We are dedicated to supporting businesses globally who are seeking consulting services for speed-to-market regulatory requirements. We do this through hands-on regulatory, clinical, quality and compliance strategies and support services. Make us a value added member of your team. Contact us to learn more about how we can assist you in navigating the complex regulatory landscape and achieving your goals.

What Our Clients Say

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"Dr. Alan has consistently demonstrated a comprehensive and up to date knowledge of regulatory requirements across multiple jurisdictions. His expertise has included:

  • Regulatory Strategy Development
  • Submission Preparation and Management
  • Post-Approval Maintenance
  • Compliance Monitoring and Auditing.

 

Dr. Alan's ability to interpret complex regulations and translate them into actionable strategies has been invaluable to our organization. He has successfully led numerous high stakes regulatory projects including the approval of our flagship product in 3 major markets."

RaShaune J.
Director of Quality and Regulatory Affairs
TAE Life Sciences