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Submissions

EAS provides assistance with submissions for all FDA industry products and facilities. With our scientific experts in areas such as toxicology, radiology, chemistry, microbiology, packaging and our in-depth knowledge of government laws and regulations, EAS consultants can lead your company through the process of obtaining necessary background data, pre-meetings with the Agency, preparation and filing of the submission and act as a conduit between the Agency and the sponsor during the review process. EAS is well known in the industry as having the highest level of of expertise and is routinely called upon for GRAS, NDI, DMF, IDEs and more

Food Submissions

  • Generally Recognized As Safe (GRAS)
  • Food and Color Additive Petitions
  • Food Contact Substance Notifications
  • Structure/Function Claim Notifications
  • Food Facility Registrations
  • Acidified & Low Acid Canned Food Filings
  • New Infant Formula Notifications
  • USDA APHIS Animal & Plant Health Permits
  • Temporary Marketing Permits

Dietary Supplement Submissions

  • New Dietary Ingredient (NDI)

Pharma Submissions

  • Drug Master File (DMF)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • New Animal Drug Application (NADA)
  • Investigational Drug Exemption (IDE)
  • Fast Tracking Applications

Medical Device Submissions

  • 510(k) Pre-Market Clearance
  • De Novo
  • Premarket submissions
  • Investigational New Devices (IND)

Tobacco Submissions

  • Pre-Market Tobacco Applications (PMTAs)
  • Modified Risk Tobacco Applications (MRTPs)
  • Substantial Equivalence (SE)

Cosmetics

  • Color Additive Petitions

Veterinary

  • New Animal Drug Application (NADA)
  • Abbreviated New Animal Drug Application (ANADA)
  • Generally Recognized as Safe (GRAS)

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