Submissions Assistance

Submissions Assistance
Product Description

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, filing the submissions, and following-up as needed during the submission process.

Examples of submissions that EAS can assist with include: Drug Master File (DMF), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drugs (IND), RX to OTC Switch, Direct to OTC NDA, OTC Time and Extent Applications and Citizen Petitions to request a change to a monograph.

EAS Consulting Group

  • US
  • 2015
    On CPHI since

EAS Consulting Group

  • US
  • 2015
    On CPHI since

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EAS Consulting Group resources (1)

  • 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