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img About ADERUS PARTNERS

Specialist GxP quality assurance and compliance consulting for life sciences and technology organizations.

ADERUS Partners helps organizations strengthen quality systems, assess and qualify vendors, manage compliance risks, and prepare for audits and inspections. Our experienced team and specialist associates bring expertise matched to each engagement.

Who We Support

Tailored support for start-ups and established organizations across life sciences and GxP technology.

  • Pharmaceutical and biotechnology companies and clinical trial sponsors
  • CROs, BA/BE centres, and specialist service providers
  • Investigator sites and clinical research centres
  • Clinical, central, bioanalytical, preclinical, and in-vitro laboratories
  • Pharmacovigilance organizations and service providers
  • IT, health-tech, medical device, and SaMD developers
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Founded by Amee Kanuga and Debabrata Roy, ADERUS Partners brings together experienced quality professionals and specialist associates. Our founders serve as lead consultants, with team expertise aligned to the scope of each engagement.

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Our Commitment to You

We work alongside you as quality partners, bringing independent judgment, practical advice, and recommendations grounded in evidence. We help management and teams identify priorities, address underlying issues, and follow through on agreed actions to strengthen quality over time.

Independent Perspective

Objective assessments informed by evidence, applicable requirements, and your quality responsibilities.

Practical Recommendations

Clear actions aligned with your processes, resources, and operational needs.

Risk-Based Priorities

Focus on participant and patient safety, data integrity, and significant compliance risks.

Flexible Engagements

Defined projects, ongoing external QA support, or targeted specialist advice.

Capability That Lasts

Training, mentoring, and collaboration that help your teams sustain improvements.

img Where to Start

What Support Do You Need?

Choose a starting point below, or tell us about your specific quality priorities.

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01

Plan an Audit or Vendor Assessment

Assess sites, vendors, laboratories, systems, and processes through independent, risk-based audits and vendor qualification assessments.

imgVendor imgAssessment
Discuss an Audit or Assesment
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02

Prepare for an Inspection

Strengthen readiness through gap assessments, mock inspections, evidence reviews, and focused preparation for your teams.

imgInspections imgReviews
Discuss Inspection Readiness
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03

Strengthen Your Quality System

Establish or improve your QMS, SOPs, quality governance, and oversight processes with support tailored to your organization.

imgQMS imgSOPs
Discuss Your Quality System
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04

Address Compliance Gaps

Investigate root causes, develop and implement corrective and preventive actions, and assess their effectiveness.

imgRoot causes imgCompliance
Discuss Compliance Gaps
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Your Requirements May Be Different. Our Support Can Be Tailored.

Whether you need a focused assessment, ongoing external QA support, specialist advice, training, or help across several quality priorities, tell us what you are working towards. We will work with you to define the scope and support you need.

Discuss Your Requirements

Independent GxP quality assurance and compliance support, tailored to your organization. Partnering with Purpose. Bringing Expertise. Building Confidence. Keep it short enough to read comfortably.

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