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Outsourced QA - Quality Assurance - QbD Group

QA Outsourcing

Simplify Quality Management with Tailored QA Outsourcing Services

Do you need to kickstart your QMS or ensure ongoing compliance without operational headaches? At QbD Group, we take over your quality assurance activities with a dedicated team of experts. From supplier management to deviation handling, we provide seamless, cost-effective solutions so you can focus on your core strategy.

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What is QA Outsourcing?

Outsourced QA involves delegating your quality management system (QMS) activities to a team of professionals experienced in life sciences regulations. Whether you need support for the entire system or specific quality functions, we provide scalable and flexible solutions to meet your organization’s needs. Key aspects of Outsourced QA:

  • Standardize processes across teams, sites, and suppliers to reduce variability and ensure regulatory compliance.
  • Flexible resourcing models that solve recruitment bottlenecks and eliminate rigid team structures.
  • Deep regulatory expertise to bridge knowledge gaps and reduce the burden of internal training.
  • Scale QA support seamlessly to meet evolving business needs and handle fluctuating workloads.
  • Proactively manage compliance risks to avoid delays, non-conformities, and costly inventory disruptions.
  • Integrate efficiently with validated systems to uphold quality standards while keeping overhead under control.
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How can we help?

QbD Group offers tailored outsourced QA services to fit your unique challenges and goals:

Access to specialized expertise

Access to specialized expertise

Outsourced providers have deep expertise and experience in niche areas ensuring accurate compliance with regulations  reducing overall risks and speeding up problem-solving. 

Optimized resource deployment

Optimized resource deployment

Remote and outsourced services offer scalability, enabling companies to ramp up or down quickly based on project needs. This flexibility can reduce delays and optimize resource use during different phases of research and development.

Faster time to market

Faster time to market

By outsourcing non-core tasks, life sciences companies can focus on their critical R&D activities, speeding up innovation. This approach minimizes bottlenecks and accelerates product development cycles, leading to quicker regulatory submissions.

24/7 operations

24/7 operations

With outsourced services in different time zones, work can continue around the clock. This maximizes productivity and shortens timelines, especially for time-sensitive projects like clinical trials or regulatory reviews.
Outsourced QA Quality Assurance - QbD Group

Why QbD Group?

When you choose QbD Group for Outsourced QA, you gain:

  • Deep functional expertise backed by seasoned service managers who bring pragmatic, senior-level guidance tailored to your field.

  • Proven success with a scalable support model that sources specialized talent from QbD Group’s expert pool as your needs evolve.

  • Customized QA solutions designed to align with your goals, backed by clear metrics and performance indicators.

  • Global delivery options with multilingual capabilities and flexible, hybrid engagement models.

  • Transparent and structured communication, including consistent progress reporting and escalation mechanisms for issue resolution.

  • Budget clarity and predictability from the outset, ensuring alignment with financial expectations and operational scope.

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What we offer: scalable and tailored Quality Assurance expertise

  • Tailored support for  your QA activities.
  • Base Business support.
  • Scalable remote workforce  (1-25 specialists).
  • Library of services: QA, QP, RP, Auditors, Lead Auditors, CAPA, Change, Deviations, technical writers, service managers ...
  • Broad sector experience: GMP/ GDP/GCP/MD/IVD/ATMP.
  • Regional experience and local expertise with competent authorities (EU GMP, US GMP, ANVISA, Health Canada …).
  • High quality standard: thoroughly  and effectively execute tasks.
  • Standardized workflows with the suggestion to optimize tools, communication, flows, service meetings and KPI’s).
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Ready to simplify your quality assurance processes?

QbD Group provides flexible Outsourced QA solutions tailored to your needs. Whether you require full system management or targeted support, our experts are here to help. Contact us today to learn more.

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Why should we outsource our quality management system?

Outsourcing helps you access specialized expertise, ensuring compliance without the overhead of managing it in-house. It allows you to focus on your core business while experts handle the complexities of quality management.

How can outsourcing improve compliance?

Outsourcing ensures that your quality system is managed by professionals who are up-to-date with ever-changing regulations. It reduces the risk of compliance errors and ensures your processes are always audit-ready.

How do you know that we and by extension our consultants are reliable?

We carefully train and maintain the experience, certifications, and track record of our consultants. You’ll have transparency throughout the process, with regular updates and performance reviews.

Can outsourcing help reduce costs?

Yes, outsourcing eliminates the need for long-term hires and overhead costs, offering a more cost-effective solution. It allows you to pay for services as needed, without sacrificing quality.

What types of quality management services can be outsourced?

You can outsource a range of services including audits, training, regulatory submissions, documentation management, batch review, supplier management, and more. This allows you to tailor the outsourcing solution to fit your needs.

How quickly can outsourcing be implemented?

The timeline depends on your needs, but we work efficiently to integrate outsourcing with minimal disruption. Typically, we can have things up and running within a month.

Will we lose control over our quality processes?

Not at all! You’ll remain in control, with the flexibility to set expectations and monitor progress. Outsourcing complements your operations, providing expert support without losing oversight.