Toolkits

12 Free Resources to Boost Your Pharmaceutical FDA Readiness

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Toolkit Videos 1 Videos 1 Registrations™ Toolkit for Pharma & Biologics Companies Pharmaceutical and biologics organizations produce medicines and treatments that save millions of lives across the globe. The world would benefit enormously if these companies bring their products to market sooner. Accelerated time to market is the impetus for the development of MasterControl Registrations for eCTD, a cloud- based solution designed to streamline content generation and the collection and management of artifacts required for regulatory submission. This toolkit includes white papers, articles, and videos that address common problems encountered by pharmaceutical and biologics companies during the submission process. These free materials collectively share practical strategies and offer best practices for increased efficiency, successful product registration, and timely product launch. FDA Just Called! Now what? Regulatory gurus Linda Chatwin and Walt Murray explain what needs to be done to maintain a continual state of regulatory readiness. They walk through the steps that should be taken when the FDA schedules an inspection, and even what to do when inspectors show up unannounced. Using MasterControl for FDA Compliance MasterControl customers in life science industries explain how automating their quality processes with a robust system has streamlined compliance and allowed their companies to become more competitive. FDA Audit Preparedness in Pharma Contract Manufacturing Learn how Contract Pharmacal Corp. has alleviated compliance concerns by maintaining a continual state of audit readiness with MasterControl.

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