Course Catalog
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Regulatory Affairs: Electronic Common Technical Document (eCTD)
$225.00 -
Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
$225.00 -
Regulatory Affairs: Essentials of Monoclonal Antibodies
$145.00 -
Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USA
$225.00 -
Regulatory Affairs: Orphan Drug Application – EU and US
$145.00 -
Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
$145.00 -
Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
$225.00 -
Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USA
$225.00 -
Regulatory Affairs: The 505(b)(2) Application for Marketing Approval in the USA
$145.00 -
Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USA
$225.00 -
Regulatory Affairs: The Decentralized Procedure (DCP)
$195.00 -
Regulatory Affairs: The European Centralized Procedure (CP)
$145.00 -
Regulatory Affairs: The Mutual Recognition Procedure (MRP)
$195.00 -
Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
$115.00 -
Regulatory Affairs: Variations to Marketing Authorizations in Europe
$225.00 -
Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)
$199.00
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