EAS Pharmaceutical Industry Services
Drugs EAS is a leading provider of regulatory consulting services to the pharmaceutical industry with over 50 years of experience assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations. Our expert consultants have advised companies on FDA pharmaceutical policies and procedures, including interpreting FDA policy and guidance documents related to cGMPs. We provide valuable assistance in the preparation of SOPs for complaint handling, recalls, change control, ISO Quality Systems, employee practices, failure investigations. In addition, our expert toxicologists review Chemistry and Manufacturing Control (CMC) submissions to FDA for completeness and accuracy.EAS auditing services to the pharmaceutical industry include cGMP, Quality System and pre-approval audits of manufacturers, laboratories and vendors, due diligence for M&A and insurance assessments, as well as “FDA mock inspections” to help firms prepare for FDA pre-approval inspections. In addition, EAS assists with guidance on import procedures and obtaining clearance of products through U.S. Customs and FDA at time of entry.EAS provides expert and thorough consulting services for all of your pharmaceutical, OTC, homeopathic, allopathic, compounding and generic needs.