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.