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
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...
by Dr. Yashashwini Reddy | Nov 5, 2024
1. The Indian Patent and Design Act, 1970 Focused on encouraging innovation, this act initially allowed only process patents, enabling Indian companies to produce affordable generic drugs. Over the years, the act evolved, aligning with international standards to...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
