1.What is RegulatoryAffairs?
Ans–Regulatory Affairs in the pharmaceutical business is a career that serves as a liaison between the pharmaceutical sector and drug regulatory bodies worldwide. It is mostly concerned in the registration of pharmaceutical goods in their various nations prior to marketing.
2.What are the goals of RegulatoryAffairs Professionals?
Ans–• Human health protection• Human health protection• ensuring medication safety, effectiveness, and quality
3.What are the Roles of RegulatoryAffairs professionals?
Ans–• Liaison with regulatory bodies • Preparation of organised and scientifically valid NDA, ANDA,INDA,MAA,DMF filings • Adherence and compliance with all applicable cGMP, ICH, GCP, GLP standards, rules, and laws• Advising firms on regulatory considerations and climate that would effect their proposed operations • In addition to the above core duties, Regulatory Affairs experts fulfil a variety of other functions.
4.What is an Investigational NewDrug(IND) application?
Ans–It is a request to the FDA seeking permission to lawfully test an investigational medicine on human volunteers in the United States.
5.What is a New Drug Application?
Ans–The NDA is the formal vehicle through which medication sponsors request that the FDA approve a novel medicine for sale and marketing in the United States. The information obtained during an investigational novel drug’s animal research and human clinical trials becomes part of the NDA.In layman’s terms, “it is an application submitted with the FDA to sell a novel pharmaceutical for sale in the United States.”