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Dossier Preparation and Submissions of New Marketing Authorizations

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Introduction

Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries.

The word 'Dossier' has the english meaning as a collection or file of documents on the particular subject, especially a file containing detailed information about a person or a topic. Any formulation is prepared for human use i.e. designated to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “Pharmaceutical product for human use”. Process of critiquing and assessing the dossier of pharmaceutical product containing its detailed about administrative, chemistry, preclinical & clinical information and the permission granted by the regulatory agencies of a country with a view to support its marketing or approval in a country is called as “Marketing approval or Registration” ,“Marketing Authorization or “ Product Licensing”.

DESCRIPTION

“Registration Dossier” of the pharmaceutical product is a document that contains all technical data (administrative, quality, nonclinical, and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in European Union (EU) and other countries as simply Registration Dossier.

Every Pharmaceutical Company’s goal is to get their product to market. Dossier preparation and submission is our core competence. Through our knowledge and experience we can assist you in navigating the sometimes complex pathways to access the various health markets FDA,EU, TGA etc.., taking the hassle out of the regulatory process and allowing you to get your product on the market without delay. We prepare and submit dossiers for Pharmaceuticals (Branded), Generics, Over-the- Counter preparations.

COMMON TECHNICAL DOCUMENT (CTD)

CTD is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labor and Welfare (Japan). The CTD is maintained by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The agreement to assemble all the quality, safety and efficacy information in a common format has revolutionized the regulatory review processes.