Next Upcoming Seminar: Dairy Processing 101 Seminar – June 13-15, 2017

Specializing in FDA Regulatory Matters

Pharmaceuticals

EAS offers a range of pharmaceutical consulting and auditing services including:

Conducting cGMP, Quality System and pre-approval audits of manufacturers and vendors.

  • Conducting due diligence audits.
  • Providing consulting services related to FDA pharmaceutical policies and procedures.
  • Interpreting FDA policy and guidance documents related to cGMPs.
  • Reviewing laboratories for compliance with GMP requirements.
  • Providing guidance on import procedures, and assisting in obtaining clearance of products through U.S. Customs and FDA at time of entry.
  • Providing recall advice and assistance as needed.
  • Preparing SOPs for complaint handling, recalls, change control, employee practices, failure investigations, etc.
  • Prepare firms for FDA pre-approval inspections by conducting “FDA-like mock inspections”.
  • Reviewing Chemistry and Manufacturing Control (CMC ) submissions to FDA.

EAS Consulting Group is proud to have expert consultants who have lead the pharmaceutical and OTC field in the U.S. marketplace. View a sampling of some former positions held by our consultants prior to joining EAS.

Glossary of Terms – Drugs