This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

Key Features:-

  • the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
  • pharmacovigilance programs designed to prevent widespread safety issues
  • legal issues surrounding the sourcing of foreign APIs
  • the issues of counterfeit drugs
  • updates on quality standards

More Details about The Pharmaceutical Regulatory Process 2e (HB)

General Information  
PublisherInforma Healthcare
BindingHard Back
Publish YearJanuary 2008