About Us

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Experience You Can Count On

Our service includes a comprehensive consultation to help identify gaps in your Regulatory or Quality Management Systems as well as opportunities for solutions.  Will help build your submissions and compliance strategies and support them where you need it.  

We can present you with  a comprehensive report that includes a project plan with timelines and milestones where appropriate, a cost proposal, and a schedule.  Our focus is on assisting you to overcome your barriers to success quickly and  smoothly. That’s how we ensure your success.

Robert van Osdel, Principal Consultant – Regulatory Affairs and Quality Assurance specialist with unparalleled experienced in new and generic drug compliance and approvals, medical device compliance and approvals, and dietary supplement compliance.  Expertise in bringing products to market and managing post-marketing requirements such as application supplements, labeling creation and revisions, manufacturing site transfers, product quality, safety and effectiveness evaluations, and pharmacovigilance.