EU-qualified person release

EU-qualified person batch release

Nuvisan offers qualified person (QP) services to support the batch release of pharmaceutical products. Our QP services help ensure compliance with GMP requirements, including overseeing the release of drug products for clinical trials and helping ensure all regulatory standards are met. The commercial EU-QP release together with EU-retesting, auditing of all relevant supply chain partners and batch record review is performed by our experienced QP team. This service is an integral part of Nuvisan's commitment to delivering safe, effective and compliant drug products to market, supported by our expertise across the pharmaceutical, biotechnology and medical device industries.

Release of commercial batches

During the certification process, our experienced QP team helps ensure the GMP compliance check and regulatory compliance in line with EU regulations. Our services include but are not limited to:

• Oversight of supply chain
• Auditing of API and drug product manufacturing sites, testing labs, storage and logistic partners
• EU retesting
• Batch record review
• Storage of reference and retention samples
• Regulatory compliance support
• Certification of batches for commercial use as well as during clinical trials.