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Quality and compliance
Rigorous standards and established standard operating procedures designed to protect your data integrity and withstand regulatory scrutiny.
Audit-ready processes for rare disease programs
Disciplined execution anchors every stage of your rare disease program. Our team operates in strict compliance with GCP and GLP regulations to ensure your clinical data remains interpretable and defensible worldwide. We maintain strict chain-of-custody protocols and provide real-time oversight to protect your results and ensure reliable outcomes.
Consistent audit success:
We successfully pass an average of five sponsor audits annually to support clinical trials across multiple phases.
FDA approval history:
We successfully completed a direct FDA audit in 2020, leading to approval of a rare disease drug.
Global regulatory familiarity:
We operate with deep familiarity across FDA and EMA regulations to ensure your data is accepted worldwide.
Mandatory staff certification:
Every team member must obtain CITI certification in GCP, GLP and GDPR guidelines before supporting any sponsor trial.
Corporate social responsibility
AGADA Biosciences understands that corporate social responsibility is an important factor in vendor qualification. We maintain an active environmental committee and conduct routine internal audits to ensure our facility operations align with modern environmental, social and governance standards.
Integrated services for rare disease programs
We deliver rigorous efficacy studies, fit-for-purpose bioassays and precision tissue handling to accelerate your rare disease program from early discovery through clinical execution.
Clinical specimen management
Protecting longitudinal data integrity with strict procedural control for frozen muscle biopsies.
Bioanalytical method validation
Pre-validated methods and fit-for-purpose bioassays designed to accurately measure critical biomarkers and accelerate rare disease drug development.
Preclinical services
Rigorous efficacy studies and established in vivo models designed to de-risk your rare disease program before human 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.
Discuss your compliance requirements
Engage our senior scientists to review our quality systems and confirm our readiness for your rare disease program.
Take a virtual tour of our Halifax facility
Explore our state-of-the-art laboratory and discover how our team manages samples from receipt through to analysis and release. In this virtual tour, you’ll see how we apply Good Clinical Practice and relevant bioanalytical regulatory expectations to protect sample integrity, carry out validated bioanalytical work and support dependable data.
Meet our leadership
