Submissions Assistance

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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.
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Submissions Assistance

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