Matches in SemOpenAlex for { <https://semopenalex.org/work/W2185108253> ?p ?o ?g. }
Showing items 1 to 83 of
83
with 100 items per page.
- W2185108253 abstract "Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. A regulatory affair is becoming increasingly influential in the overall drug development process and is increasingly populated by highly trained scientists and medical professionals. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of drugs. This article will focus the similarities and differences in drug approval process of Europe, USA & Indian regulatory bodies. Years ago, a regulatory affair was often just a place where paperwork was done. There is still a lot of paperwork, although much of it is now in electronic format, but science and strategy now take precedence. So this paper point up the comparative regulatory approval process & requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India." @default.
- W2185108253 created "2016-06-24" @default.
- W2185108253 creator A5003606823 @default.
- W2185108253 creator A5013380734 @default.
- W2185108253 date "2013-01-01" @default.
- W2185108253 modified "2023-09-27" @default.
- W2185108253 title "Study of Drug Regulatory Approval Process and Comparative Requirement of Common Technical Documents (CTD) in Europe, USA and India in Coordination with Drug Developmental Process" @default.
- W2185108253 cites W2068911031 @default.
- W2185108253 cites W2324045075 @default.
- W2185108253 hasPublicationYear "2013" @default.
- W2185108253 type Work @default.
- W2185108253 sameAs 2185108253 @default.
- W2185108253 citedByCount "0" @default.
- W2185108253 crossrefType "journal-article" @default.
- W2185108253 hasAuthorship W2185108253A5003606823 @default.
- W2185108253 hasAuthorship W2185108253A5013380734 @default.
- W2185108253 hasConcept C111919701 @default.
- W2185108253 hasConcept C138885662 @default.
- W2185108253 hasConcept C142724271 @default.
- W2185108253 hasConcept C144133560 @default.
- W2185108253 hasConcept C17744445 @default.
- W2185108253 hasConcept C2778137410 @default.
- W2185108253 hasConcept C2778917124 @default.
- W2185108253 hasConcept C2779652045 @default.
- W2185108253 hasConcept C2780035454 @default.
- W2185108253 hasConcept C2780511413 @default.
- W2185108253 hasConcept C2991908516 @default.
- W2185108253 hasConcept C2992293740 @default.
- W2185108253 hasConcept C3116431 @default.
- W2185108253 hasConcept C39549134 @default.
- W2185108253 hasConcept C41008148 @default.
- W2185108253 hasConcept C41895202 @default.
- W2185108253 hasConcept C64903051 @default.
- W2185108253 hasConcept C71924100 @default.
- W2185108253 hasConcept C98045186 @default.
- W2185108253 hasConcept C98274493 @default.
- W2185108253 hasConceptScore W2185108253C111919701 @default.
- W2185108253 hasConceptScore W2185108253C138885662 @default.
- W2185108253 hasConceptScore W2185108253C142724271 @default.
- W2185108253 hasConceptScore W2185108253C144133560 @default.
- W2185108253 hasConceptScore W2185108253C17744445 @default.
- W2185108253 hasConceptScore W2185108253C2778137410 @default.
- W2185108253 hasConceptScore W2185108253C2778917124 @default.
- W2185108253 hasConceptScore W2185108253C2779652045 @default.
- W2185108253 hasConceptScore W2185108253C2780035454 @default.
- W2185108253 hasConceptScore W2185108253C2780511413 @default.
- W2185108253 hasConceptScore W2185108253C2991908516 @default.
- W2185108253 hasConceptScore W2185108253C2992293740 @default.
- W2185108253 hasConceptScore W2185108253C3116431 @default.
- W2185108253 hasConceptScore W2185108253C39549134 @default.
- W2185108253 hasConceptScore W2185108253C41008148 @default.
- W2185108253 hasConceptScore W2185108253C41895202 @default.
- W2185108253 hasConceptScore W2185108253C64903051 @default.
- W2185108253 hasConceptScore W2185108253C71924100 @default.
- W2185108253 hasConceptScore W2185108253C98045186 @default.
- W2185108253 hasConceptScore W2185108253C98274493 @default.
- W2185108253 hasLocation W21851082531 @default.
- W2185108253 hasOpenAccess W2185108253 @default.
- W2185108253 hasPrimaryLocation W21851082531 @default.
- W2185108253 hasRelatedWork W1553877438 @default.
- W2185108253 hasRelatedWork W1600278927 @default.
- W2185108253 hasRelatedWork W191587705 @default.
- W2185108253 hasRelatedWork W1976739527 @default.
- W2185108253 hasRelatedWork W2115210435 @default.
- W2185108253 hasRelatedWork W2150562680 @default.
- W2185108253 hasRelatedWork W2186152676 @default.
- W2185108253 hasRelatedWork W2250861633 @default.
- W2185108253 hasRelatedWork W2313067917 @default.
- W2185108253 hasRelatedWork W2492832573 @default.
- W2185108253 hasRelatedWork W2621826230 @default.
- W2185108253 hasRelatedWork W3007440683 @default.
- W2185108253 hasRelatedWork W3126419832 @default.
- W2185108253 hasRelatedWork W3144492386 @default.
- W2185108253 hasRelatedWork W3146991908 @default.
- W2185108253 hasRelatedWork W3211592293 @default.
- W2185108253 hasRelatedWork W2183754834 @default.
- W2185108253 hasRelatedWork W2187738970 @default.
- W2185108253 hasRelatedWork W3088101200 @default.
- W2185108253 hasRelatedWork W3182379325 @default.
- W2185108253 isParatext "false" @default.
- W2185108253 isRetracted "false" @default.
- W2185108253 magId "2185108253" @default.
- W2185108253 workType "article" @default.