Good Manufacturing Practices - Regulatory Assistance and Audits

Good Manufacturing Practices - Regulatory Assistance and Audits
Product Description

EAS consultants offer the best in Pharmaceutical Good Manufacturing Practices (GMP) compliance audits and facilitate an understanding of how to implement quality programs that meet FDA expectations. FDA ensures the quality of pharmaceuticals in the US marketplace through a system of GMPs, providing a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors. While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business.

Read more Show less

EAS Consulting Group

  • US
  • 2015
    On CPHI since
View company profile
Categories
more categories Show less

EAS Consulting Group

  • US
  • 2015
    On CPHI since
View company profile

More Products from EAS Consulting Group (2)

  • Assistance with FDA Inspections

    Product Assistance with FDA Inspections

    EAS Consulting Group is available to provide a mock FDA inspection of domestic and foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction. 



  • Submissions Assistance

    Product Submissions Assistance

    EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filin...

EAS Consulting Group resources (1)

  • EAS - Services Offered to the Pharmaceutical Industry

    Brochure EAS - Services Offered to the Pharmaceutical Industry

    EAS provides a variety of FDA based regulatory services to the global Rx and OTC pharmaceutical industry.We offer a seamless approach to help your organization navigate the regulatory intricacies associated with product development, submissions, claims and labeling,manufacturing and packaging of commercial products,as well as facility and product registrations and listings. Our team of pharmaceutical regulatory experts are ready to provide assistance in; the development of filing and quality strategies, GMP/GLP/GCP assessments, Mock-FDA Inspections and reviews, quality management system development, regulatory submissions, product labeling and claims compliance, and a number of other topics  that will help your organization succeed in this highly complex and very competitive regulatory environment. EAS is committed to helping the members of domestic and international pharmaceutical market understand,meet and sustain compliance with the FDA’s numerous requirements in a manner t