EAS Consulting Group, LLC (EAS) is a leading provider of regulatory consulting services to the pharmaceutical industry. The firm has over 50 years of experience assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations. Employing a unique team of former Food and Drug Administration (FDA) officials and industry experts, EAS offers unparalleled expertise with most consultants having more than 30 years of FDA experience.
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.