Regulatory Insights
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Sponsor Overcomes Hold And Steers Products Through Development
11/2/2023
Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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Medical Writing Support Relieves A Burdensome Review
11/2/2023
Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.
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Adopt Tech Solutions To Innovate And Streamline Regulatory Services
10/30/2023
See how transformative technologies like AI and ML augment the regulatory professional workload to ensure compliance, patient accessibility, and rapid timelines for approval for global drug campaigns.
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Regulatory Portfolio Management: From Bad To Gold
10/30/2023
Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.
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Fast-Tracking Your Product Development With An IDP
10/30/2023
Explore how a customized Integrated Development Plan assisted in the removal of guesswork and obstacles from a startup's development roadmap, enabling it to move with speed and remain competitive.
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A Successful Pre-IND Enabling Next Stage Of Development
10/30/2023
Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.
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Effective Clinical Evaluation Preparation Enables EU MDR Compliance
10/30/2023
Uncover how one company was able to ensure that its European products remained on the market through outsourced preparation of high-quality Clinical Evaluation Reports (CERs) for submission to Notified Bodies.
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Advanced Therapy Medicinal Products: Recent US Approvals, Upcoming Guidance
10/29/2023
Explore the 2022-2023 approvals of ATMPs by the Center for Biologics Evaluation and Review and the newly named Office of Therapeutic Products.
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Reimagining Clinical Studies To Support Anticancer Products
10/29/2023
Understand why more frequent surveillance and a reevaluation of the clinical studies are required to support Accelerated Approval for anticancer products.
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Prepare For ICH E6(R3) GCP When You’re Still Struggling With (R2)
10/29/2023
Get strategies to confidently navigate revisions to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline.