Drug safety effects every step of the medication use process. By proactively conducting risk assessments during product development it is possible to avoid pitfalls and mitigate errors. There are inherent risks in drug brand development caused by name similarity, visual brand mishaps, package and label shortcomings, trade dress commonality, and more. By combining regulatory rigor with creative strategy, we help clients meet global health agency requirements while fostering commercial potential.

Dr. Max Straka

Dr. Maximilian Straka, PharmD, FISMP

Director, Drug Safety

Medication Error Mitigation

Safety is the top priority. Any other opportunity a name or brand may enjoy is compromised if safety isn’t respected. MedERRS®, the Drug Safety Division of Leaderboard Branding, is integral to all projects – bringing a trained and expert perspective on potential medication error mitigation. This perspective allows Leaderboard to provide partners with unique insight – improving branding decisions and supporting successful and safer outcomes.

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Risk Assessment

Mitigating errors to create safer products starts with understanding where errors may occur. By undergoing a robust risk assessment using Failure Mode and Effects Analysis (FMEA), Leaderboard is able to predict potential errors, understand levels of frequency or severity, and make strategic adjustments in the pursuit of safer products. Internal expertise joined with in-field perspective give Leaderboard’s partners the data and support to mitigate potential errors and make more confident decisions.

Risk Mitigation Action Plans

Creative problem solving is proven through experience. Whether developing a brand with safety in mind, or addressing real-world challenges were medication errors have already occurred, Leaderboard has a depth of knowledge and expertise to generate solutions that make brands safer. Clearly articulating challenges, outlining smart plans and executing to perfection – these together set Leaderboard apart in medication error prevention.

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Drug Safety

Regulatory Name Submission Strategy & Documents
Name Safety Research / Gap Analysis
Consults & Rebuttals
Global Regulatory Name Submission White Papers
Regulatory Strategy
Medical Panel Evaluation
Global Name Justification / Rebuttal Development
Label & Packaging Development
Medication Error Package Re-Design
Regulatory Consulting & Training