Types of audits

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From on-site to remote audits to vendor questionnaires, we provide support to a variety of organisations, including sponsors, CROs, CDMOs, and large healthcare organisations. Different partners have different requirements, and we have built our support network around those requirements, which continue to evolve as our community grows with new partners coming on board. We work in partnership with customers, helping them develop as much as they push us to innovate our solutions.

Drug Product/Drug Substance
Excipients/Raw Materials & Consumables
Contract Research Organisations & Clinical Investigator Sites
Trial Master Files (TMF) & Good Clinical Laboratory Practice (GCLP)
Nonclinical Laboratories and Pre-Clinical Services
Warehouse/Distribution Centres
CSV, Data Integrity & Ancillary Services (Software, Pest Control, etc.)

Audit community

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Our community of SMEs supports many of our client projects, and our support network extends globally across all GxP and ISO requirements. With most of our network within North America, Europe and Asia, we do have small hubs of highly skilled consultants.

Europe

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • UK

North America

  • Canada
  • USA

Asia

  • China
  • India
  • Israel
  • Japan

South America

  • Brazil
  • Chile
  • Argentina
  • Mexico

Africa

  • Nigeria
  • Egypt
  • South Africa
  • Kenya

Oceania

  • Australia
  • New Zealand
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ISO & CSV

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GCP & GCLP

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GVP/GPvP

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GLP

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GDP

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GMP

Elevate compliance, ensure quality

At RRxCo, we specialise in delivering comprehensive audit services tailored to your unique needs. Our goal is to ensure your operations and suppliers meet the highest regulatory standards, ensuring product safety, efficacy, and compliance.

Why choose us?

Our team of seasoned professionals brings extensive experience in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and other GxP & ISO regulations. We provide in-depth audits that cover all aspects of your operations, from laboratory procedures to clinical trials and manufacturing processes.

Customised audit solutions

We understand that each organisation is unique. Our audits are tailored to address your specific regulatory requirements and business needs. Whether you need a comprehensive compliance assessment or targeted audits, we deliver solutions that are precise and effective.

Proactive risk management

Identifying and mitigating risks before they become issues is crucial. Our proactive approach ensures potential non-compliances are detected early, providing you with actionable insights to implement corrective measures swiftly.

Enhancing your systems

Our audits don't just focus on compliance; they also aim to enhance your quality systems. We provide detailed reports and practical recommendations that help you streamline operations, improve efficiency, and maintain continuous improvement.

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300+

Audits completed

100%

Of GxP and ISOs covered

100%

Clients passing regulatory inspection

<14days

Average audit report turnaround time

Internal audits

Regular assessments to ensure ongoing compliance with relevant and applicable standards.

External audits

Evaluating your suppliers and partners to ensure they meet your expected and required standards.

Commitment to excellence

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Partnering with us means you benefit from a commitment to excellence, integrity, and professionalism. We work closely with your team to ensure a thorough understanding of your processes and deliver audits that not only meet but exceed regulatory expectations. By leveraging these advantages, life science companies can enhance their supply chain integrity, ensure regulatory compliance, and maintain high standards of product quality and safety.

Expertise

Consultants bring specialised knowledge of regulatory standards and industry best practices, ensuring thorough, accurate audits.

Objectivity

External auditors provide an unbiased perspective, identifying issues that internal teams might overlook.

Efficiency

Consultants streamline the audit process, saving time and resources, and allowing internal teams to focus on core activities.

Risk Management

Consultancy firms offer actionable insights and recommendations to enhance supplier quality and compliance.

Continuous Improvement

Professional auditors identify and mitigate potential risks, ensuring compliance and preventing costly non-compliance issues.

Training and Development

Consultants can provide training for internal staff, improving their knowledge and competence in auditing and compliance.

The process

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We have developed a simple and smooth process with continuous client feedback for ensuring accurate, best-in-class and an enjoyable audit process.

Day 1

Audit Requirement Indentified

  • Appropriate Risk Assessment applied either by you or with RRxCo support.
Day 2

Client Requests Audit & Completes Pre-Qualification Process

  • Templates provided (tailored to client if required).
Day 3

Statement of Work (SOW)

  • Whether for a singular audit or an entire schedule support.
Day 4

Audit Agenda Generated

  • Template(s) provided (tailored to client if required).
Day 5

Relevant Stakeholders Informed (Client, Vendor, Lead Contacts)

  • Introduction by you to relevant stakholders or RRxCo supports the entire process.
Day 6

Dates & Agenda Confirmation

  • Templates provided (tailored to client if required).
Day 7

Travel Cost Approval & Booking

  • Template provided (tailored to client if required).
Day 8

Audit Execution

  • Template provided (tailored to client if required).
Day 9

First Draft Report

  • Typically, 14 days post audit date.
Day 10

Report Comments Reviewed

  • Report comments discussed, addressed and agreed.
Day 11

Audit Report Approved

  • All relevant stakeholders approve Audit Report.
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