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8 Obstacles in Pharma Product Registration & Submission Management

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1. DROWNING IN DOCUMENTATION Registration requires a complex compilation of information coming from various functional areas. The information is often repurposed globally for multiple submissions. The paperwork can be daunting. 7. INTEGRATION WOES Most companies use different systems to manage the electronic submission compilation process and publish in-house, while some outsource the work. to a vendor. Regardless of process, the capability to integrate systems and connect with vendors is crucial. 8. INEFFECTIVE COLLABORATION There used to be only one type of collaboration: linear. Stakeholders took turns reviewing and editing a document. Today that process is not good enough. To stay competitive, content contributors need the capability for simultaneous editing, preferably in real time. 6. ENDLESS HUNT To rely on a spreadsheet for tracking means constantly hunting down artifacts and their owners. Worse, a spreadsheet never reflects an accurate point-in-time status. Drug development is a lengthy and costly process, doubly so for pharmaceutical companies that rely on manual processes. To register and market their products across the globe, they must address these common obstacles. 2. LACK OF CONTROL Regulatory affairs (RA) professionals usually see the documents for submission after they are approved by other teams. Manual tools put RA at the mercy of other stakeholders. 3. LACK OF VISIBILITY RA must manage all applications and respond to requests for information and clarification from regulatory agencies. A manual process lacks the visibility of registration projects and contributors scattered in various geographic locations. 4. INEFFECTIVE PROJECT MANAGEMENT A spreadsheet doesn't scale to the complexities of managing requirements, changes, and timelines. RA needs the capability to see all activities and information relevant to a product for timely updates whenever something changes. Obstacles In pharma product registration & submission management 5. REGIONAL DIFFERENCES Although the electronic Common Technical Document (eCTD) format provides consistency within the industry, there remains a regional aspect to submissions. RA needs to be able to quickly see the countries where each product is registered, the products registered in every country, and all artifacts related to each product by country. Learn more about this topic. Read the white paper: T op 8 Obstacles in Pharma & Biologics Product Registration & Submission Management For more information visit www.mastercontrol.com

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