Building Bridges for Better drug development to: Integrating Global Expertise for Drug Development
We take an integrated approach to drug development by aligning global teams and connecting data across functions to support efficient development and informed decision-making.
Your Partner for Success
Accelerate Global Development of Novel Therapeutics.
Amador Bioscience provides an integrated portfolio of services, in strict accordance with global standards, to facilitate drug development throughout all stages. These services encompass translational science, clinical pharmacology, and regulatory submission support.
Our translational science and regulatory affairs teams, led by experienced industry professionals, provide integrated support to advance drug candidates from nonclinical studies through first-in-human clinical trials.
From Nonclinical to Clinical Development
From IND to NDA
We deliver strategic clinical pharmacology expertise and advanced modeling and simulation to support development from IND through NDA, including regulatory interactions and global submission support.
Our integrated approach leverages clinical pharmacology to enable evidence generation and informed, data-driven decision-making. Our experts guide quantitative analysis, model-informed drug development, and translational strategies to support progression and key regulatory milestones.
From Local to Global Market
With clinical pharmacology teams across the U.S., Europe, and China, we support global drug development and access to major international markets.
Our cross-regional experts work in close alignment to ensure consistent scientific strategy, regulatory readiness, and coordinated global development.
As your development partner, we integrate expertise across regions to support efficient progression and informed decision-making¡ªso you can focus on advancing therapies that improve patient outcomes worldwide.
2018
20
1600
+
+
The idea of establishing a comprehensive drug development consultancy became a reality in 2018.
Our expert team has over 20 years of average experience in the drug development industry.
We completed more than 1600 studies ¡ª from preclinical to BLA/NDA ¡ª in the first five years of our existence.
Our Ambition
At Amador Bioscience, we apply scientific expertise and industry experience to guide development decisions. Our goal is to bring together experts with deep knowledge across all stages of drug development, working as an extension of our clients¡¯ teams.
We believe informed, evidence-based decisions are critical to successful drug development and better patient outcomes. Our promise is to help teams make confident, timely decisions¡ªusing quantitative insight to guide program strategy, optimize study design, and move development forward with clarity.
Our Promise
Our Expertise
We support the success of your trial with a global network of therapeutic-specific key opinion leaders, subject-matter experts, vendors, and pre-qualified investigator trial sites. Our experts will help you bring new therapies to market safely and quickly in a number of therapeutic areas.
