Rare disease expertise. One integrated path from lab to clinic.
AGADA Biosciences is a lean, fully integrated CRO specializing in rare diseases. We provide the scientific expertise and strict quality control required to de-risk development and progress your program.
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110+
trials in mouse models of muscular dystrophy
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60+
Phase I, Phase II and Phase III human studies
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3800+
biopsies successfully observed and processed
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400+
published SOPs for standards-compliant results
A comprehensive service offering
We support biotech, pharma and research teams with dedicated expertise in rare diseases. By combining rigorous science with a collaborative approach, our team works to de-risk development, protect data integrity and progress programs forward faster.
We provide support from preclinical efficacy studies through to regulatory approval, as well as post-market research for comprehensive program support.
Clinical specimen management
Our infrastructure and workflows ensure we actively oversee tissue processing at clinical sites. AGADA also partners with designated molecular assay labs and third-party vendors for more specialized clinical specimen management.
Bioanalytical method validation
Pre-validated methods and optimized bioassays designed to accurately measure select biomarkers and maintain momentum in the development of rare disease therapies.
Pre-clinical services
AGADA provides comprehensive preclinical research services designed to de-risk drug development programs for rare diseases. Our team partners with sponsors to design and execute rigorous efficacy studies in validated mouse models, generating functional, histological, and biomarker data under a robust QA/QC framework.
Backed by internationally recognized standard operating procedures and experience from hundreds of preclinical studies, AGADA delivers regulatory-ready data that supports proof of concept, orphan drug designation, and confident progression to clinical trials.
Translational strategy consulting
Successful rare disease programs begin with the right strategy. AGADA’s senior scientific team provides expert translational and regulatory guidance to help you define study objectives, select meaningful biomarker endpoints, and generate evidence that supports confident decision-making. By aligning your program with FDA and EMA expectations from the outset, we help reduce risk and accelerate development.
About AGADA
Founded in 2013 by Drs. Kanneboyina Nagaraju and Eric Hoffman, AGADA Biosciences is a leading contract research organization (CRO) specializing in rare disease research.
Originally developed in Children’s National Medical Center, AGADA was established to provide rigorous preclinical efficacy testing, advanced biomarker and muscle biopsy analysis, and specialized support for clinical trials. Today, operating from a 17,000 sq. ft. state-of-the-art facility in Halifax, Nova Scotia, AGADA combines scientific expertise with standardized, high-quality laboratory services to accelerate the development of new therapies for rare diseases.
Need to get in touch?
Speak to our team today to find out more about the CRO services we offer and how we can de-risk your program.
Why AGADA?
AGADA Biosciences is a trusted partner for pharmaceutical and biotech organizations developing therapies for rare diseases. With deep scientific expertise spanning preclinical, clinical development and post-launch research, AGADA delivers comprehensive support for efficacy testing in validated disease models to muscle biopsy management, biomarker assay development, and regulatory guidance.
Our standardized, high-quality processes, global tissue logistics capabilities, and proven expertise in supporting accelerated approval pathways help clients generate reliable data, reduce development risk, and move promising therapies toward patients with confidence.
Strict quality control
Providing quality assurance with AGADA’s Quality Management System (QMS) and culture of accountability.
Specialized scientific support
Our multidisciplinary team are experts in their given fields with the specialist skills required to deliver high-quality outputs.
Regulatory rigor
Preparing robust programs fit for the regulatory submission process.
Our story and purpose
Discover why AGADA was founded and the purpose that continues to drive our work today. With roots in Duchenne muscular dystrophy (DMD) research, AGADA brings specialized expertise to every stage of drug development.
News and resources
Stay up-to-date with the AGADA team’s latest developments.
