What information do you need from us to start the APR?

We'll need access to relevant product data, batch records, quality metrics, and previous review documents. We'll guide you through the data collection process to ensure everything is in place.

Can you handle complex products with multiple components?

Yes, we have experience with complex products and multi-component systems. Our team ensures every component is properly assessed.

How do you manage confidential product information?

We follow strict protocols to handle your product data securely. All information is shared only within our trusted team.

What if we have multiple products that need APRs?

We can handle APRs for multiple products simultaneously, ensuring consistency and streamlining the process.

How do you address issues or deviations found during the APR?

We identify deviations during the review and provide clear recommendations for corrective actions, complete with a detailed action plan.

Can you integrate our existing quality management system into the APR process?

Yes, we align with your existing QMS to ensure the review process integrates seamlessly with your internal procedures.

How will we know the APR is completed on time?

We provide a clear timeline and regular updates, so you always know when to expect the completed review.

Annual Product Review (APR) & Product Quality Review (PQR)

Streamline your APR and PQR processes with expert support

QbD Group offers full support for Annual Product Review and Product Quality Review — from data analysis and PQR writing to compliance review. These mandatory reviews ensure product quality, safety, and market readiness.

What is APR/PQR Support?

An APR or PQR evaluates product quality and performance to ensure safety, compliance, and market readiness. QbD Group provides end-to-end support for the entire process, from crunching the data to compiling comprehensive reports.

Key aspects include: comprehensive data management — gathering, processing, and analyzing data from multiple systems, regulatory compliance — ensuring all reviews meet GMP standards, detailed reporting with proposed action plans, and yearly insights providing trend analysis across PQRs.

Why are APR/PQRs important?

Patient safety

APR and PQR processes detect potential risks, ensuring products meet safety standards and safeguarding patient health.

Supply chain stability

Timely reviews prevent production setbacks and stockouts, ensuring consistent product flow.

Sales and market reputation

Up-to-date reviews ensure regulatory approval and timely market readiness, protecting your company's reputation.

How can we help?

QbD Group offers tailored APR/PQR services to meet your organization's unique needs:

Deadline management

Ensuring timely completion of all reviews.

PQR writing

Compiling comprehensive reports ready for approval.

Data analysis and statistics

Crunching numbers and identifying trends.

Review for compliance

Ensuring consistency and regulatory alignment.

Our process

QbD Group offers tailored APR/PQR services to meet your organization's unique needs, including deadline management, PQR writing, data analysis, and compliance review.