In English term Dossier means a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Dossier in pharma helps to create, assemble, update and publish composite documents from various individual document sources and formats.
Tammina manages all documents as a single, consistent, structured and unified document. Tammina helps you to save time from assembling and maintaining constantly moving documents. Tammina can manage regulatory procedures on your behalf.
Tammina can help you with Registration Dossier of the pharmaceutical product. The registration dossier for medicines is an important document which is submitted for review to regulatory agencies by pharma companies for approval to market their medicines.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 known as New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU).
Dossier Management consists of mainly three aspects –
- Planning – Tammina Regulatory professionals gets the total knowledge for deadlines for filing a dossier. Experts understand the registration requirements of different agencies. Experts work on individual documents and send them to respective departments.
- Formatting and compilation – Tammina expertsbelieve in decorating the dossier as per the formatting rules and compilation rules. Experts take care of all the formatting of a document such as, information should be unambiguous and transparent, Font size and Font text. Experts make sure that the dossier follows the guidelines of formatting.
- Reviewing – Tammina expertshas a habit of reviewing the data before implementing. Experts also cross verify the document by a person other than who made it. Experts have a checklist of Dos which is very important for ANDA.