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Dietary Component Specifications and Testing

Dietary Component Specifications and Testing

Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Specifically, industry continues to face challenges in complying with the specification and testing requirements for dietary supplement components.

Health Canada

Health Canada

Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.

Good ANDA Submission Practices

Good ANDA Submission Practices

Good ANDA Submission Practices Proactive Planning for the Best Possible Outcomes Presented by Radhika Rajagopalan, Ph.D., EAS Independent Consultant FDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to...