![]() ![]() Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?Įvery country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.Is the drug’s proposed labelling (package insert) appropriate, and what it contain?.Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?.The goals of the dossiers are to provide enough information to permit Regulatory Agencies’ reviewers to establish the following: Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. “Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval or the “Registration” “Marketing Authorization” or the “Product Licensing”. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. All you have to do is to click here and submit your correction.Rohtak, word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. So if you encounter any problem in our translation service please feel free to correct it at the spot. Although we have added all of the meanings of Dossier with utmost care but there could be human errors in the translation. This will improve our English to Urdu Dictionary, Urdu to English dictionary, English to Urdu Idioms translation and Urdu to English Idioms translations. We encourage everyone to contribute in adding more meanings to MeaningIn Dictionary by adding English to Urdu translations, Urdu to Roman Urdu transliterations and Urdu to English Translations. ![]() We have tried our level best to provide you as much detail on how to say Dossier in Urdu as possible so you could understand its correct English to Urdu translation. If you have trouble reading in Urdu we have also provided these meanings in Roman Urdu. ![]() These idioms or quotations can also be taken as a literary example of how to use Dossier in a sentence. If there is a match we also include idioms & quotations that either use this word or its translations in them or use any of the related words in English or Urdu translations. In case you want even more details, you can also consider checking out all of the definitions of the word Dossier. Some of these words can also be considered Dossier synonyms. To understand how would you translate the word Dossier in Urdu, you can take help from words closely related to Dossier or it’s Urdu translations. Meanings of the word Dossier in Urdu are. ![]()
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