Pharmaceutical Regulatory Affairs

Regulations and its executions is core part of Pharmaceutical industry. The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and preparing documents for import-export and other market formalities.  DBCOP’s Department of Pharmaceutical Regulatory Affairs (PRA) train students on understanding, interpretation, preparation of formats given by regulatory authorities of different countries. Students are meticulously trained in required set of skills including - regulatory knowledge, critical thinking, writing skills, oral communication, organisational skills, business skills. Hands on (practical) training on e-CTD and other regulatory submission formats are given using software and live projects. Collaborations with pharmaceutical companies and regulatory experts facilitate sharing of their expertise and live projects with students.