Quality & Compliance
Rigorous Quality Standards for Globally Compliant Preclinical Data
Our commitment to quality ensures your preclinical data is robust, reproducible, and ready for regulatory submission anywhere in the world.
Quality is the Foundation of Every Program
In drug development, data quality is not optional — it is the difference between a successful IND filing and a costly delay. vivoPharm embeds quality principles into every aspect of our consulting work, from study design through data interpretation.
Our Quality Standards
GLP Compliance
We provide expert guidance on Good Laboratory Practice requirements, ensuring your studies meet the standards required for regulatory submission. Our consultants have extensive experience with GLP study oversight and quality assurance.
ICH Guidelines
Deep expertise in ICH guidelines (M3, S1-S9, E8) ensures your preclinical program is designed and executed in alignment with international regulatory expectations across FDA, EMA, and PMDA jurisdictions.
FDA & EMA Alignment
We stay current with evolving FDA and EMA guidance documents, ensuring your program reflects the latest regulatory expectations and avoids common pitfalls that delay submissions.
Data Integrity
Robust data management practices, including ALCOA+ principles, are embedded in our study oversight and review processes to ensure the integrity and traceability of all preclinical data.
Our Quality Process
Protocol Review
Every study protocol is reviewed against current regulatory guidance before initiation, identifying gaps and risks before they become costly problems.
CRO Qualification
We assess and qualify CROs against GLP standards and your specific study requirements, ensuring the right partner for every study.
Study Monitoring
Active oversight throughout study execution, with regular progress reviews and early identification of deviations or issues.
Data Review & Audit
Comprehensive review of raw data, reports, and supporting documentation to ensure completeness, accuracy, and regulatory compliance.
Report Review
Final study reports are reviewed for scientific accuracy, regulatory compliance, and clarity before inclusion in your IND package.
Build Your Program on a Foundation of Quality
Contact us to discuss how our quality and compliance expertise can protect your program and accelerate your path to the clinic.
Discuss Quality Requirements