Global Regulatory Affairs Career Roadmap
Are you ready to take your regulatory affairs career global? Regulatory Affairs is one of the most dynamic and in-demand domains in... Read More
What is CDSCO Form CT-07B?
Form CT-07B is used for the registration and renewal of Clinical Research Organizations (CROs) with the Central Drugs Standard Control Organisation (CDSCO)... Read More
Do dossier should always be prepared in CTD format?
Posted on02 Nov 2024
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No, a dossier does not always have to be prepared in the Common Technical Document (CTD) format, although this is the preferred... Read More
What is IPQA in Pharma?
IPQA (In-Process Quality Assurance) in the pharmaceutical industry ensures that products are manufactured according to stringent quality standards throughout the production process.... Read More
medical device regulatory affairs vs. quality assurance
The roles of medical device regulatory professionals and quality assurance (QA) professionals are distinct but complementary. Both work towards ensuring that medical... Read More
What is the difference between 505j application, 505b1 NDA & 505b2 NDA?
In this topic we will be discussing about 505j, 505b1 and 505b2 application and differences between all 3 applications. The 505(j), 505(b)(1),... Read More
What are the difference between FDA 483 and Warning Letter?
483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and... Read More
What is Biologic License Application (BLA)?
A Biologic License Application (BLA) is a submission to the USFDA requesting permission to market and distribute a biologic product. Biologic products... Read More
What are the difference between regulatory affairs and pharmacovigilance working?
Posted on21 Feb 2024
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Pharmacovigilance professionals deals with the adverse effects, and regulatory professionals work on registration and regulation of drug. Pharmacovigilance professionals are focused on... Read More
Significance of Schedule H1 Drugs
Followed by the recent notification by Government of India (GOI) to omit 40 drugs from Schedule H, the drugs are included in... Read More