by Dr. Yashashwini Reddy | Apr 8, 2025
Feature Regulatory Affairs Quality Assurance Focus Legal compliance and market access Product quality and consistency Scope Entire product lifecycle, with an emphasis on regulatory requirements Entire product lifecycle, with an emphasis on quality standards Primary...
by Dr. Yashashwini Reddy | Apr 8, 2025
Various types of regulatory submissions are essential in the pharmaceutical and medical device industries. These include Investigational New Drug (IND) applications for clinical trials, New Drug Applications (NDAs) for new pharmaceuticals, Biologics License...
by Dr. Yashashwini Reddy | Apr 8, 2025
Clinical Research Associate (CRA): CRAs are tasked with overseeing clinical trials, ensuring adherence to protocols and regulations, and safeguarding the integrity of data. Clinical Research Coordinator (CRC): CRCs are responsible for the daily management of clinical...
by Dr. Yashashwini Reddy | Apr 5, 2025
The career paths in Pharmacovigilance or Drug Safety are both – knowledge and skill-based. One’s educational background in the field of medicine, be it – a physician, a dentist, a pharmacology student (and so on) – along with the skill sets acquired...
