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Qualified Person (QP) & Responsible Person (RP) Services - Quality Assurance - QbD Group

Qualified Person (QP) & Responsible Person (RP) Services

Seamlessly meet regulatory requirements with expert QP and RP support

Do you need a Qualified Person (QP) or Responsible Person (RP) to ensure compliance and product release? At QbD Group, we provide experienced professionals to help you meet mandatory requirements, maintain compliance, and ensure operational continuity. From batch release to compliance monitoring, our experts are here to support your organization’s needs.

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What is QP/RP Support?

The roles of Qualified Person (QP) and Responsible Person (RP) are mandatory for ensuring the quality and compliance of pharmaceutical products and distribution. These professionals oversee compliance with regulatory requirements, manage product release, and ensure adherence to marketing authorizations. Key aspects of QP/RP support:

  • Regulatory compliance: Ensuring compliance with GMP or GDP standards.

  • Batch release oversight: Monitoring and approving product batches for release.

  • Documentation and record-keeping: Managing compliance documentation for audits and inspections.

  • Flexible support: Offering full-time, interim, project-based, or part-time engagement.

  • Specialized expertise: Providing advanced knowledge in life sciences regulations and practices.

Discover why QPs and RPs are essential

Qualified Person (QP) & Responsible Person (RP) Services - Quality Assurance - QbD Group (1)

Why is QP/RP support important?

Having a QP or RP is mandatory for pharmaceutical companies, importers, and distributors. These roles are critical for ensuring:

  • Product release: Compliance with regulatory standards is required for products to enter the market.

  • Audit readiness: Proper documentation and adherence to regulations mitigate risks during inspections.

  • Operational continuity: Qualified professionals fill essential roles, preventing disruptions.

  • Regulatory expertise: Knowledgeable professionals ensure compliance with evolving regulations.

 

Discover how we can support you

How can we help?

QbD Group provides tailored QP and RP services to meet your regulatory and operational needs:

Full-time support

Full-time support

Dedicated QP or RP to manage ongoing operations and compliance.

Interim support

Interim support

Temporary coverage during audits, absences, or workload peaks.

Project-based assignments

Project-based assignments

Support for specific projects like product launches or inspection readiness.

Part-time engagement

Part-time engagement

Flexible oversight and batch review without full-time commitment.

On-demand expertise

On-demand expertise

Access to QPs or RPs for urgent tasks or regulatory challenges.

Qualified Person (QP) & Responsible Person (RP) Services - Quality Assurance - QbD Group (2)

Why QbD Group?

When you choose QbD Group for QP/RP services, you benefit from:

  • Immediate availability: Quickly fill critical roles without delays.

  • Industry-leading expertise: Access professionals with advanced knowledge in GMP and GDP.

  • Tailored solutions: Flexible engagements designed to meet your specific needs.

  • Proven track record: Trusted by life sciences organizations worldwide.

  • Scalable support: Expand or reduce support to match your workload and regulatory needs.

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Our process

1. Initial consultation

We discuss your specific needs and regulatory requirements.

2. Candidate selection

We present qualified QP/RP candidates based on expertise and compliance knowledge.

3. Onboarding

The QP or RP integrates into your operations, ensuring a smooth transition.

4. Ongoing support

Continuous engagement to meet your compliance and operational goals.

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Get in touch

Need a Qualified Person or Responsible Person to ensure compliance?

QbD Group provides tailored QP/RP services to help you meet mandatory requirements and maintain operational continuity. Contact us today to learn more.

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What qualifications should a QP or RP have?

A Qualified Person (QP) or Responsible Person (RP) should hold relevant degrees in life sciences and certifications that meet regulatory standards such as GMP or GDP. They must have extensive experience and knowledge of EU or FDA regulations.

How quickly can a QP or RP be hired through QbD?

Depending on your needs, a qualified QP or RP can typically be available within a few weeks.

Can a QP or RP work remotely?

Yes, many tasks like compliance documentation and oversight can be done remotely. However, certain responsibilities, such as batch release, may require on-site presence.

How do you ensure the QP or RP stays compliant with regulations?

Our QPs and RPs stay updated through industry courses and certifications. Regular feedback and performance reviews ensure high compliance standards.

What if we need a QP or RP for a short-term project?

We offer flexible, short-term engagements for audits, product launches, or regulatory submissions, providing support without a long-term commitment.

Will we lose control over our compliance processes?

Not at all! You remain in control while our QPs and RPs provide expert support to complement your operations.