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Send Me Future News & Information

We provide a wide range of regulatory compliance, regulatory affairs, and regulatory submission services, for example:

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  • FDA/GMP regulations review

  • FDA/FTC questions

  • IND preparation and filing

  • IRB protocol preparation and filing

  • Regulatory review and evaluation of consumer labels and labeling

  • Review of promotional, advertising printed materials, product disclosures and other documentation to ensure regulatory compliance

  • Creation of product regulatory dossiers for product marketing and global product registrations and renewal

  • Completion of audit questionnaires, third party Global Compliance Assessment and global platform

  • Medical food application preparation and filings

  • Statistical analysis

  • Project Management

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OUR MISSION

Our mission is to advance products with proven science by providing

the top clinical trial, clinical study, basic science research, medical

writing and consulting services to the natural nutrition products industry.

OUR VALUES

We are passionate about science, research, medicine and nutrition. We apply our passion and professionalism to everything we do. Accuracy and rigor are cornerstones of our business, and we are committed to delivering careful and meticulous work for our customers.

 

We value a team-oriented approach and focus on building and maintaining long-term relationships with our clients, investigators,

and clinical sites to create sustainable alliances.

Regulatory Management

and consulting services

© 2017  Medical Nutrition Research and Development Enterprise of America

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