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Quality
Systems

Quality and regulatory compliance
throughout your product life cycle

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Quality
Systems

Build up quality and compliance
with speed and minimum risk

the Minerva way

Minerva quality and regulatory experts
by your side from the start

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 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.

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Expert coverage for your product and industry

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.


Integrated KM and QRM

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.


Phase-appropriate compliance architecture

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 from early on in you development work.


Assured compliance during commercialization and market surveillance

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.

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All the controls necessary to comply

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 hierarchy, covering every operational and quality aspect. Each document is optimized for execution, adherence, and accessibility.


Compliance for clinical trials and commercialization

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.


Rapid response for regulatory inspections

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.

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A team of compliance specialists with how-to experience in:
  • Regulatory inspection response: Effectively address and resolve inspection findings.
  • Gap assessment and mitigation: Identify and bridge compliance gaps.
  • Quality management systems: Develop and optimize robust quality systems.
  • Risk management: Proactively identify and mitigate quality and compliance risks.
  • Technical writing and documentation: Ensure clear, accurate, and compliant documentation.
  • Audit preparation and preventive remediation: Prepare for audits and proactively address potential risks.

A collaborative remediation process with clearly defined activities:
  • Identify: Conduct a detailed review to uncover compliance gaps or regulatory issues.
  • Assess: Analytically evaluate and prioritize issues based on compliance, product, and process quality risks.
  • Plan: Develop a strategic action plan with clear timelines, responsibilities, and resources, using easily accessible databases for transparency, and collaboration.
  • Implement: Collaboratively implement solutions to correct non-compliance and enhance systems.
  • Monitor: Continuously monitor and audit changes to ensure effectiveness and sustained compliance.
  • Finalize: Validate, verify, and formally close the remediation process.

Sustainable quality and compliance for the benefit of patients

the Minerva way