Quality and regulatory compliance
throughout your product life cycle
the Minerva way
Our team of quality and regulatory experts provides guidance to ensure your company meets industry standards, laws, and regulations across various markets and therapeutic areas throughout your product’s life cycle.
We begin as early as in product and process definition, equipping your company to build up the highest compliance standards and Good Manufacturing Practices (GMP) across process development, GMP process definition, and clinical trials.
Minerva’s regulatory compliance team of experts ensures your quality system is designed and built in alignment with your industry’s best practices, using successful compliance benchmarks to guide you through the applicable regulatory framework.
Our practical, phase-appropriate approach to quality and compliance integrates visual-digital compliance capabilities with an integrated knowledge management (KM) and quality risk management (QRM) framework to create compliant processes and systems throughout your product’s complete life cycle.
Minerva helps you implement a solid data governance and data integrity framework, good documentation and laboratory practices (GDPs and GLPs), and overall knowledge governance, to facilitate sustained data and knowledge-based decisions with full traceability early in you development work.
Our expert team provides rapid remediation of quality and compliance gaps during commercialization, quickly reducing risks while preparing you for a continuous manufacture. Our proactive approach considers both operational performance and compliance, accelerating time-to-market while building up a positive regulatory profile.
Minerva develops advanced, reliable control documents to proactively address current and potential compliance failures. Our comprehensive documentation spans all levels of your company’s document pyramid, covering every operational and quality aspect. Each document is optimized for execution, adherence, and accessibility.
Our comprehensive compliance risk reduction services consider operational performance and quality processes, for a positive regulatory profile during clinical trials, commercialization readiness, and accelerated time-to-market.
Facing a regulatory inspection? Minerva’s expert team offers immediate support, including strategic guidance, remediation management, and thorough execution.
We handle the entire inspection process, minimizing operational disruptions while helping you confidently resolve your regulatory situation.
the Minerva way
