In the age of outsourcing, drug and device manufacturers depend on their suppliers for critical activities, making them vulnerable to potentially devastating quality issues.

On top of this, many manufacturers continue to operate under the false assumption that by handing over duties to suppliers, so to go the responsibilities for maintaining regulatory compliance. This is not the case.

Although it's in suppliers' interests to keep themselves to a high standard of quality to attract clients, the regulatory burden ultimately rests on the company receiving their products or service.

Monitoring and managing quality is extremely important when outsourcing anything that could potentially impact the product.

Routine and pre-qualification audits of suppliers and service providers are our primary focus, we work with you to understand your concerns and we customize our audit to fit your needs. Our auditors are ISO 13485:2016 lead auditor certified and are ASQ Certified Quality Auditors.

Smaller companies struggle with meeting internal audit requirements. Building a qualified internal audit team can be a struggle and lead to less than ideal results.

Outsourcing your internal audit program can maintain your compliance without causing excessive burden to your staff. Using a contract internal auditor can be more effective allowing your operation to be observed objectively without bias.

We can work with you to design an internal audit program consisting of quarterly, combined system audits, that are very budget friendly.

The FDA may be knocking on your door any day - are you ready?

Knowing that a pre-approval inspection is in your future or just anticipating a regular visit from the agency can be nerve wracking. Are your employees prepared to face FDA investigators who are trained to thoroughly investigate a manufacturer’s entire operation? Are you confident that your subject matter experts (SMEs) are ready? No matter how intelligent, well-educated and capable your people are, they can slip-up and lead investigators through doors you might prefer to keep closed.

Is your team ready for the logistics of an upcoming regulatory audit? Is your back-room set-up to function seamlessly with the audit room? Will they buckle under pressure?

NQS can provide pre-inspection consulting and training for select staff or SMEs. We can perform unannounced mock inspections to test your team’s readiness before the big day.