ALEXANDRIA, Va., Dec. 19, 2017 /PRNewswire/ -- EAS Consulting Group, LLC is very pleased to welcome Albert Yehaskel as the new Independent Advisor for Pharmaceutical Submissions. In this role, he will provide expert advice and guidance, while continuing to provide independent consulting to EAS clients in the development, technical review, strategy and filing process for submissions such as Investigational New Drugs (INDs), Drug Master Files (DMFs), New Drug Applications (NDAs), Biological Drug Applications (BLAs), Annual Reports (INDs and NDAs/BLAs), Abbreviated New Drug Applications (ANDAs) etc. His expertise will allow clients to have a thorough understanding of their particular requirements under FDA law as well as how the various studies, filings and amendments/supplements are integrated for a high quality submission package.
Mr. Yehaskel joined the EAS network as an Independent Consultant in 2015. He is an accomplished professional with a distinguished record in pharmaceutical regulatory affairs activities. Mr. Yehaskel has been consulting since 2010 and spent 41 years in industry, serving as vice president of regulatory affairs, compliance and safety at Indigo Pharmaceuticals, Inc., and in regulatory roles at Shionogi USA, Sankyo Pharma Development, Purdue Pharma and Sanofi Winthrop. Mr. Yehaskel assists clients with the development, review and filing of pharmaceutical submissions to FDA.
Mr. Yehaskel joins a team of EAS Independent Advisors who are leaders in their fields in developing regulatory compliant strategies, providing expert regulatory advice:
Steven Armstrong, J.D., Independent Advisor for Food Law and Regulation
John Bailey, Independent Advisor for Colors and Cosmetics
Charles Breen, Independent Advisor for Food Safety Modernization Act
Elizabeth Campbell, Independent Advisor for Labeling and Claims
Susan Crane, Independent Advisor for OTC Drugs and Listings
Robert Fish, Independent Advisor for Quality and Compliance
Robert L. Martin, Independent Advisor for Food and Color Additive Safety
Jeffrey Springer, Independent Advisor for FDA Regulatory and Legal Matters
Timothy Stewart, Ph.D., Independent Advisor for Dietary Supplements
Stephen Sundlof, D.V.M., Ph.D., Senior Advisor for Animal and Human Food Safety
Domenic Veneziano, Independent Advisor for Import Operations
Ed Steele, EAS Chairman and CEO and Dean Cirotta, President and COO are pleased that EAS continues to provide high level technical consultation for clients, and the appointment of Albert Yehaskel to Independent Advisor continues to keep EAS at the forefront in its ability to provide pertinent leadership in all areas of FDA regulatory compliance.
About EAS Consulting Group, LLC
EAS Consulting Group specializes in FDA regulatory matters in the supplement, pharmaceutical, medical device, food, tobacco and cosmetics industries. 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 mock inspections".
- Reviewing Chemistry and Manufacturing Control (CMC) submissions to FDA.
- OTC to Cosmetic Switch, Homeopathic, Allopathic
- ISO Quality Systems
Contact Bryan J. Coleman, 571-447-5504
SOURCE EAS Consulting Group, LLC