Case objective

A biopharmaceutical company based outside of Europe developed a novel biological drug, intended for therapeutic use in oncology. Like other global manufacturers from countries without mutual recognition agreements (MRA) who wish to import their products within the European economic area (EEA), they needed to have their batches retested in EU prior to batch release. The product was manufactured in a third country and had not yet been introduced to the European market. The client aimed to initiate a marketing authorisation application (MAA) in the European Union under the centralised procedure, using the common technical document (CTD) format.

Our approach and impact

Given the complexity of European regulatory requirements — particularly for biologics — expert guidance was essential to help ensure that the supply chain, quality systems and documentation met European expectations. This included compliance with EU-GMP standards (annex 16), QP oversight and batch release readiness. Nuvisan supported the client throughout the entire preparation phase for entering the European market. As part of it, QA/QP activities were critical because they helped ensure regulatory compliance, product quality and patient safety. A Nuvisan qualified person (QP) certified that each batch met EU GMP standards, thereby supporting our clients in selling their products in Europe.

Our case-specific key technologies

Facing similar challenges? This is how Nuvisan´s experts in quality assurance can help you ensure compliance with EU GMP regulations through QA/QP oversight

Nuvisan’s team has several QPs and is certified as an importer and manufacturer of human, veterinary and investigational medicinal products. Providing expert guidance, we help ensure that all quality and GMP-related elements comply with EU standards. Additionally, EU retest of finished products (small molecules or biologics) can be supported through our certified laboratories.

Our services include:

• Gap analysis: identify gaps between existing documentation and EU regulatory requirements
• QP declarations:
  • Support the preparation of QP declarations by verifying GMP compliance across the manufacturing sites of the supply chain sites
  • On-sites GMP audits in all countries involved in manufacturing, QC testing, storage and distribution of drug substance and drug product manufacturing sites
• Authorisation of importation requests to the medicine’s agency
• EU retest: finished product testing in Nuvisan EU-certified labs
• Batch review: evaluate batch records and quality data to ensure conformity before QP release
• QP certification and release
• Sample storage: provide secure EU-based storage for reference and retention samples
• Stability studies: manage stability testing programs according to ICH guidelines and EU requirements
• Lifecycle monitoring: conducting annual product quality reviews and helping ensure ongoing regulatory compliance post-launch.