Abstract: A method and system provide for automatically evaluating a request for regulatory compliance approval. The method makes use of historical data that includes information extracted from prior requests for regulatory compliance approval that have previously been submitted by multiple requesting organizations and information extracted from prior responses to the prior requests, provided by at least one regulatory body. A prediction model may have been trained on the historical data. A new request for regulatory compliance approval or new data for generating the new request is received from a requesting organization. New information is extracted from the new request or from the new data for generating the new request. Based on the extracted new information and the historical data (e.g., using the prediction model), a proposal for a response to the new request is generated. Access to the proposal is provided to a regulatory body reviewing the new request.

Abstract: A method and system for regulatory compliance aggregates a set of report forms in a repository. Each report form is associated with one or more regulatory agencies. In response to a request for the compliance data of a product that is going to market, the system matches the product to the relevant form(s) in the repository. The system then guides the steps of populating and completion of regulatory compliance reports for each vendor (corresponding to the different source materials or operation used in producing the product or service) in the value chain. On a vendor-by-vendor basis, the system selectively redacts proprietary information from the compliance report, and transmits the partially redacted compliance report to the other vendors that are cooperating in the product production. Further, the system completes a report for each agency involved in the marketing and, more particularly, transmits only the data required by a corresponding agency thereto.