All substances are toxic above a certain dose. Appropriate doses make the difference between poisons and medicines. According to Paracelsus, no drug is completely safe or effective under all circumstances, but it is moral that the manufacturers involved take appropriate steps to ensure optimal quality, safety, and efficacy. It is legally expected. Regulatory operations serve as a roadmap for the development of prescription drugs, biologics, and medical devices. Regulations focus on harmonization with international regulations, new drug applications, good manufacturing practices, quality system compliance, documentation requirements, clinical trial exceptions, expedited status, advisory board procedures, and other compliance issues.

1 RESEARCH METHODOLOGY 

2 RESEARCH OBJECTIVES 

3 RESEARCH PROCESS 

4 SCOPE & COVERAGE

5 REPORT ASSUMPTIONS & CAVEATS 

6 MARKET AT A GLANCE 

7 INTRODUCTION 

8 MARKET OPPORTUNITIES & TRENDS 

9 MARKET GROWTH ENABLERS