Dossier

Our organisation helps to prepare / submit and custom clearance of DOSSIER and final order dispatch.

A dossier is a comprehensive collection of documents submitted to regulatory authorities for the approval of pharmaceutical products in any country. It includes detailed information on the product's composition, manufacturing process, quality control measures, clinical trial data, and safety and efficacy profiles. Dossier compliance ensures that the product meets the stringent regulatory requirements of the target market, facilitating its registration and commercialization.

For example, when registering a new drug in the European Union, a pharmaceutical company must compile a Common Technical Document (CTD) dossier. This dossier is divided into five modules: Administrative and Prescribing Information, Overview and Summaries, Quality, Non-Clinical Study Reports, and Clinical Study Reports. Each module must adhere to specific guidelines to ensure the product's safety, efficacy, and quality standards are met before it can be approved for market entry.