nda drug applications formatting regulatory regulations submissions training seminars workshops and conferences in AA

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Your search for 'nda drug applications formatting regulatory regulations submissions' training seminars workshops and conferences in US and Canada has produced the following results.

 Format for Making Regulatory Submissions to Ensure a Quicker Approval Webinar

 

Category: Compliance-Regulation

Training Provider: Online Compliance Panel

Learn to organize new drug applications ;NDAs abbreviated new drug applications ;ANDAs and biological license applications;BLAs for FDA submission.

      
 

 New Requirement for Electronic submission of Drug Master Files (DMFs): What you need to know Webinar

 

Category: Compliance-Regulation

Training Provider: Online Compliance Panel

In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.

      
 

 Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device Webinar

 

Category: Compliance-Regulation

Training Provider: Online Compliance Panel

This webinar ensures your company gets a broader perspective of how and what to do to get a quick and non-debatable or questionable approval for your 510K product. All are different so this presentation will not just be specific for a specified Medical Device that is currently being marketed and your company wants the same opportunity to produce and sell that product.

      
 

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