Registration and Submission

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  • Published date: May 23, 2019
    • Shirley, New York, United States

The so-called drug registration and submission represents that the state food and drug administration (FDA), in accordance with the application of the drug registration applicant, makes a systematic evaluation of the safety, effectiveness and quality controllability of the drugs to be sold along with the legal procedure, and then decides whether to agree with the procedure for approval of the application. The complex and time-consuming registration process of pharmaceuticals and biologics is becoming more and more challenging for companies that are developing new technologies to comply with increasingly stringent regulations and health services. Despite the extremely complex technology, BOC Sciences has the expertise and long-term experience in preparing and submitting drug and biologicals registration documents to the health sector in various areas of treatment.

Moreover, during the review process, BOC Sciences will prepare and respond to the enquiries from the health department as required and provide the necessary regulatory support until the application is formally approved. After approval, BOC Sciences will maintain your IND/CTA application or sales license through the following services. Learning how our outsourced publishing solutions ensure quality and eliminate your regulatory publishing overhead costs, please contact us for your inquiry.

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