EAS Consulting Group, LLC is pleased to welcome Susan Crane as the new Senior Advisor for Over-the-Counter (OTC) Drugs and Labeling. Ms. Crane has been an EAS Senior Consultant since 2014 and has been instrumental in helping clients navigate the challenging FDA regulations pertaining to OTCs, their monographs and labeling requirements. Her addition to the senior leadership team further solidifies EAS as the leading consulting company in regulatory matters pertaining to all FDA regulated areas including OTCs, pharmaceuticals, cosmetics, dietary supplements, foods, medical devices and tobacco.
Ms. Crane’s extensive experience encompasses all phases of the marketing, labeling and distribution of both OTC drugs and dietary supplements, with special emphasis on the labeling requirements mandated in the OTC drug monographs and the associated format and content regulations. In addition, she advises clients on adverse event reporting, drug listing and issues related to both Consumer Product Safety Commission poison prevention packaging and Federal Trade Commission advertising and promotion regulations.
Ms. Crane joins a team of EAS Senior Advisors, leaders in their fields in developing regulatory compliant strategies:
- John Bailey, Senior Advisor for Colors and Cosmetics,
- Anthony C. Celeste, Senior Advisor for Pharmaceutical Regulatory Affairs,
- Nancy Chew, Senior Advisor for New Product Development and Submissions,
- William (Bill) Ment, Senior Advisor for GMP Audit Services,
- Robert L. Martin, Senior Advisor for Food and Color Additive Safety,
- Jeffrey Springer, Senior Advisor for FDA Regulatory and Legal Matters,
- Elizabeth Campbell, Senior Advisor for Labeling and Claims,
- Stephen Sundlof, D.V.M., Ph.D., Senior Advisor for Animal and Human Food Safety,
- Tara Lin Couch, PhD, Senior Advisor for Dietary Supplements
Ed Steele, EAS Chairman and CEO, and Dean Cirotta, President and COO, are pleased that EAS continues to provide such a high level of technical consultation for our clients. Ms. Crane will provide a valuable service to OTC drug clients who are looking to bring products into the marketplace in a regulatory, compliant manner.
About EAS Consulting Group, LLC
EAS Consulting Group specializes in FDA regulatory matters in the supplement, pharmaceutical, medical device, food, tobacco and cosmetics industries, including assistance in tailored compliance trainings, 483 responses, mock-FDA audits, labeling compliance and more. EAS is staffed with former industry experts and FDA officials who have expertise in both FDA policies and enforcement.