Preparation of Regulatory Filings and Submissions
Schiff & Company, Inc. has prepared numerous regulatory submissions including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Investigational New Drug Applications (IND), Premarket Notifications (510(k)), Investigational Device Exemptions (IDE), Biologics License Applications (BLA), Premarket Approval Applications (PMA), Drug Master Files and Device Master Files (DMF), and similar applications in other countries including Marketing Authorizations in Europe, and New Drug Submissions (NDS) in Canada. The company has experts in both traditional paper preparations and the latest techniques for the preparation of electronic submissions using the electronic Common Technical Document (eCTD) format. Citizen's petitions, 75 day notices, color additive petitions, and requests for designation 513(g) are also developed and written.
Schiff & Company, Inc. provides guidance and assistance in compliance with government regulations for all aspects of the pharmaceutical product and medical device development cycles. The Company maintains constant surveillance of the rapidly changing regulations of the United States and other countries in order to provide the best assistance in bringing to market prescription drugs, over-the-counter drugs, biologics, medical devices, and diagnostic tools.
Schiff & Company, Inc. represents many foreign firms as their United States Designated Agent.
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