ROSETTA Pyramid™ is a centralized repository and portal for all communications records and documents between a Life Sciences company and regulatory authorities.

ROSETTA Pyramid enables a Life Sciences company to collect, categorize, index, track and archive the company’s interactions with regulatory authorities. No matter whether it’s a submission to a regulatory authority, correspondence from an authority, fax, email, phone conversation or face-to-face meeting, the interaction record/event can be tracked in the system and the associated documents can be stored in an integrated electronic document management system (such as EMC Documentum) for instant retrieval.

If your Regulatory Affairs and Regulatory Operations departments are challenged by not being able to view an integrated context and timeline of interactions with regulatory authorities and to quickly retrieve detailed information and documents in order to prepare submissions or respond to inquiries efficiently, you are not alone. DoubleBridge Technologies' ROSETTA Pyramid can help. Used by multiple leading Life Sciences companies globally, ROSETTA Pyramid has been helping our customers to solve the following business challenges:

• There is no efficient way to see the chronology of interactions, incoming or outgoing, related to a product, drug application, specific topic, timeframe, etc.
• Inability to quickly find submission documents electronically as regulatory personnel are trying to communicate with the health authorities – thus resulting in wasted time and delays in resolving regulatory questions.
• There is no convenient and reliable way to retrieve the complete set of information and documents as they are stored in several disconnected systems, repositories or tools.
• Inability to effectively answer questions about where and when submission or study documents have been sent because the links from authored submission documents to the detailed contents of a compiled/assembled submission are not readily searchable.
• As submission documents are being written, assembled, published and ultimately sent to regulatory authorities, the same metadata is being entered multiple times in the process.
• Submissions prepared in the Electronic Common Technical Document (eCTD) format are stored in a different system separated from submissions prepared in legacy formats because the new eCTD viewing system can not store legacy submissions, or vice versa.
• Regulatory personnel are relying on creating their own spreadsheets for the interactions related to their products.

ROSETTA Pyramid comes with an integrated, web-based, full lifecycle eCTD Viewer, the ROSETTA Phoenix, to provide you the true all-seeing power in one single system.