Description
Seller-provided details for this listing.
Worldwide regulatory agencies and their role
Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market]
Post-market regulatory obligations
GLPs: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP.
Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market]
Post-market regulatory obligations
GLPs: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP.