Regulatory Sciences
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Key Considerations For A Successful Launch In Nordic Markets
12/10/2024
Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.
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How To Create Successful Pricing And Reimbursement Of Your Pharmaceutical Product In The Nordics
12/10/2024
Improve your understanding of the pricing and reimbursement landscape in the Nordic countries and improve your market access in the region.
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FDA Drug Labeling Requirements & Regulations: What's In Your Label?
11/12/2024
Explore the critical role of labeling and how a comprehensive approach enables alignment with clinical trial design, ensuring the label accurately reflects the product’s strengths and intended use.
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FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements
11/6/2024
The eSTAR template, mandatory for 510(k) submissions, simplifies FDA reviews but presents new challenges. Learn about expert support for smooth transitions and effective regulatory compliance.
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Labeling Development & Intelligence
10/28/2024
A labeling intelligence solution supports comprehensive product development, regulatory, and safety strategies, and efficient lifecycle management for successful product outcomes.
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Drug Development Program Management
10/28/2024
Learn how a consultant helped a biotech company specializing in immuno-oncology to develop timeline reports for the product and portfolio and identify and address gaps in the filing plan.
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Implementation of the New European Health Technology Assessment Regulation (HTAR)
10/28/2024
The European Health Technology Assessment Regulation (HTAR) requires joint clinical assessments for certain therapies starting 2025, impacting market access preparation for companies in the EU.
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The Impact Of A US Government Shutdown On The Food And Drug Administration
10/28/2024
An impending government shutdown threatens FDA operations, potentially delaying reviews and communications; Discover how companies help sponsors navigate these challenges and maintain regulatory progress.
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EU Pharmaceutical Legislation Reform: Where Are We Now?
10/28/2024
The EU's new pharmaceutical legislation proposes updates affecting exclusivity, regulatory timelines, and compliance, with significant implications for drug development planning.
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Beyond The Trifecta: Best Practices For A Successful PRC Process
9/17/2024
Learn how to transform your promotional review committee into a well-oiled machine by developing and implementing best practices to enhance efficiency and reduce frustration.