GxP Professional Services

We provide tailored services to help life sciences companies streamline compliance, accelerate innovation, and build lasting expertise. Our team brings deep regulatory, technical, and operational know-how to every engagement.

Why Genari?

With deep expertise in the life sciences domain, we bring a thorough understanding of complex regulatory landscapes and industry standards. Our approach is grounded in risk-based, efficient compliance methods that streamline processes while maintaining the highest levels of quality and integrity. We focus on developing practical, forward-looking strategies that empower organizations to innovate confidently, ensuring compliance enhances progress rather than slowing it down.

Translating Concepts into Clinical Applications

Our team bridges business, IT, and compliance to transform innovative concepts into real-world processes and systems. We support regulatory pathways, clinical study execution, and market access strategies that align innovation with regulatory and patient safety requirements.

eQMS Process & Systems

We design and optimize electronic Quality Management Systems (eQMS) to simplify compliance and drive operational efficiency. Our expertise spans Veeva, TrackWise, Greenlight Guru, and Dot Compliance, with support for policy development, process streamlining, documentation control, and MES integration.
GxP Compliance Strategy

From early development to commercialization, we help organizations navigate complex regulatory landscapes. Our services include 510(k)/PMA submissions, EU MDR and CE Mark compliance, ISO 13485 implementation, ISO 14971 risk management, and readiness for Class III devices, IVDs, and UDI/EUDAMED requirements.
Remediation

When issues arise, we provide hands-on remediation support to restore compliance and prevent recurrence. Our team manages regulatory responses (e.g., FDA 483s), CAPA investigations, complaint handling, change control, post-market surveillance, pharmacovigilance, clinical study oversight, and deviation management.
Audit Readiness

We prepare organizations for inspections by FDA, MDSAP, and Notified Bodies such as TÜV, Dekra, and BSI. Services include mock audits, FDA BIMO readiness, front- and back-room support, and documentation control — ensuring you are confident and inspection-ready.
Validation

We deliver end-to-end validation services, spanning design controls, process equipment qualification, calibration, and computerized system validation (CSV/CSA). Our risk-based approach ensures compliance while reducing “validation debt” and accelerating project timelines.