Consulting
EAS serves the industries of Food (including USDA), Pharmaceutical, Dietary Supplements, Medical Device, Tobacco, Biologics, Cannabis, and Cosmetics.
We provide assistance with labeling and claims, preparation of highly technical submissions, overview and preparation of requirement documents and procedures such as Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMPs), Response to FDA 483s and Warning Letters, remediation and consent decrees, recall assistance, US Agent services and more. In addition, we also provide regulatory support for law firms including expert witness services, as well as insurance firms as part of a mergers and acquisitions due diligence review.
Regulatory Strategies
Training
Recall Assistance
FDA Enforcement Actions
Due Diligence Assessments
Insurance Assessments
SOP Assistance
Submission Assistance
GMP Compliance
Facility & Laboratory Audits
Mock FDA Inspections
US Agent Services
Import Entry Assistance
Registrations and Listings
Product Labeling
Marketing Claims
Electronic Records
Quality System Implementation
Virtual Consulting Services
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