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MBPharmaco Consulting

Executive Summary

MBPharmaco Consulting provides strategic clinical pharmacology and model-informed drug development (MIDD) expertise to pharmaceutical and biotechnology companies across early and late-stage development.

With four decades of industry experience, we support translational decision-making through integrated PK/PD, biomarker, exposure–response, and simulation-based approaches to optimise candidate selection, dose strategy, and clinical development planning.

Our expertise spans oncology, biologics, immunology, and complex translational pharmacology, supported by high-quality regulatory documentation and submission-ready clinical pharmacology deliverables.

Our mission is to accelerate development decisions and support the timely delivery of innovative medicines to patients.

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Services We Offer

Quantitative Clinical Pharmacology Plan

Accelerate your drug development by leveraging QCP principles and Model-informed drug development (MIDD). Our experienced team offers strategic guidance on clinical strategy and the design, execution, analysis, and reporting of clinical pharmacology studies.

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Model-informed Drug Development

Achieve better decision-making, minimise risk and reduce development costs with our MIDD services. We leverage quantitative clinical pharmacology to optimise drug development strategies and support regulatory submissions.

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Regulatory Writing & Submissions

MBPharmaco Consulting offers expert clinical pharmacology regulatory writing assistance for NDA/BLA regulatory submissions (2.7.1 & 2.7.2) on a global scale. Our team collaborates closely with clinical pharmacology teams, ensuring the timely delivery of high-quality documents.

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Contact us today to learn more about how we can help your company succeed in the competitive pharmaceutical industry.

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