Dossier is a set of well structured document prepared by a pharmaceutical drug manufacturer. The manufacturer submits, solely at his discretion to the appropriate regulatory agency / authority in the intended drug market.

In the United States, a Dossier is submitted to the Food and Drug Administration (FDA) Agency. There is no requirement by law or FDA regulation to present a Dossier. The document may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
SoluSoft Document Management and Workflow solutions are capable to manage the Dossier submissions to various regulatory agencies and customers with proper versioning and folder structure. The final version of the Dossier can then be packed as cut into a Compact Disk for submission. Below is a list of Dossier features supported by SoluSoft solutions.

Dossier Management

• Store and archive electronic copy of all Dossiers (US / Europe / Branded market / South Africa/ Australia/ Canada/ New Zealand, Institutions and Organizations) sequentially in a well organized folder structure.
• Manage Dossier with proper versions and variations
• Store and archive electronic copy of all Variations and  Annual Updates/ Query response to Dossier submitted to Authority and its direct linkage to original submission
• Store and archive electronic copy of all Tenders, Packing Material related to Registration and Re-registration for branded markets
• Store and archive list of all TAD Review, Mfg. Lic., EPO, Approved TMD’s, Validation Reports, Validation BMR’s, Validation BPR’s, Stability Reports and Approved Artwork given for referring Dossier
• Store and archive CMC, Labeling, ICH, Biopharmacentric and BE data, PSUR’s

Reports

• Electronic Listing of all submissions
• Queries reported to Authority product wise and responded to customers

Search

• Search on Product Code, Dossier number, Dossier version, Customer, Regulatory agency or document based on folder structure.
• Custom search