Application Notes & Case Studies
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Regulatory Review Of Promotional Materials
11/8/2023
Delve into the challenges, objectives, solutions, and achievements of a regulatory review project undertaken by a mid-size pharmaceutical company across the European Union (EU), Asia-Pacific (APAC), Latin America (LATAM), and the Middle East.
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Life-Saving Treatments Reach Patients Faster
11/6/2023
Follow LivaNova's journey as they search for a solution to simplify and streamline trial initiation and management processes to expedite the delivery of life-saving devices.
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Bringing Expertise To Clinical Trials
11/6/2023
Discover how Veristat achieved improved efficiency and enhanced control over its clinical trials.
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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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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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Successful Management Facilitates Marketing Application Prep
10/30/2023
See how this small clinical-stage biotech team was able to adopt greater responsibility and accountability and embrace the criticality of structure and timelines through evaluation and mentorship.
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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.