03 Consulting service
Regulatory Strategy, Quality & Inspection Readiness
Regulatory compliance and quality are integral to every aspect of clinical research operations.
Drawing upon extensive experience leading FDA and sponsor audits, developing quality assurance programs and overseeing regulatory operations, we provide strategic guidance to strengthen organizational compliance and inspection readiness.
Our experience spans ICH-GCP requirements, quality management systems, SOP development, risk identification, internal process assessments and cross-functional regulatory oversight.
We help organizations integrate quality into day-to-day operations while maintaining the agility required to meet evolving clinical development priorities.
Who we work with
Built for organizations at a turning point
- Sites preparing for FDA or sponsor audits
- Organizations building a QA function
- Networks harmonizing quality systems
- Leadership teams strengthening compliance
How we work
From assessment to lasting performance
- 1
Assess
An honest look at where the organization stands today: workflows, people, infrastructure, compliance and performance.
- 2
Design
A practical plan: operating models, procedures, metrics and priorities sized to your goals and resources.
- 3
Implement
Hands-on support turning the plan into practice alongside your leadership and teams.
- 4
Sustain
Measures, accountability and leadership capability that keep performance improving after the engagement.
Questions
Frequently asked
Can you help us prepare for an FDA inspection?
Yes. Inspection readiness is central to this service. Founder Srishti Arora has led FDA and sponsor audits with zero findings and has established organizational quality assurance infrastructure.
What does ICH-GCP compliance support include?
We assess processes against ICH-GCP requirements, strengthen quality management systems and SOPs, identify risks, and build cross-functional regulatory oversight so compliance holds up day to day, not only before an audit.
We do not have a formal quality assurance program. Where do we start?
With an internal process assessment. From there we help design a quality assurance program and quality management system sized to your organization.
Connect with us
Let’s build what’s next
Strategic guidance for organizations advancing the future of clinical research.
Partner with Aralia Group to strengthen operations, unlock growth opportunities and build the organizational foundation for long-term success.