Pharma Regulatory Affairs (12 months)

Aim and Objectives

This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.


The course has been framed with the following objectives:

  • To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
  • To create experts in the field of RA documentation and research
  • To help students build their career in RA and become RA professionals.
  • To provide students with a global knowledge of Regulatory Affairs.



Program Fee

BII Program Participation Fee for this program is Rs. 10,300 for participants based in India (USD 750 for overseas participants ). Payment is to be made through Demand Draft / At Par Cheque in favor of "Bioinformatics Institute of India payable at Noida/Delhi ." 

Course Modules

  • Module I- Pharma Regulation Practices and Procedure
  • Module II- Pharma Patents, IPR and Regulation
  • Module III- Pharma Regulatory Regime in USA, EU and India
  • Module IV- Clinical Trials & Regulation
  • Module V- Good Manufacturing Practices, Quality Assurance and Regulation
  • Module VI- Regulatory Compliance for Pharma and Biotech Products
  • Research Study


Any Science Graduate

Examination Fees:

Every student has to pay Rs. 300/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module

Career Opportunities

Pharma Regulatory Affairs Consultant
Regulatory Officer