For pharmaceutical manufacturers seeking seamless entry into the European Union market, our comprehensive service package offers a robust and reliable EU Batch Release solution. Entrust your valuable products to our expert care from GMP-compliant testing to final market approval. Our unified approach to GMP batch testing and release encompasses a full spectrum of critical services:

• Rigorous Batch Testing: We conduct thorough batch testing strictly aligned with your approved product specifications, ensuring quality and compliance.
• Proactive Importation Authorization: We expertly initiate and manage Importation Authorization requests with the relevant Medicines Agency, streamlining the regulatory process.
• Seamless EU Importation: Our team handles all aspects of importing your drug products (both human and veterinary) into the European Union, ensuring adherence to all regulations.
• Integrated Logistics Management: We manage the entire logistics chain, including warehousing, meticulous sampling procedures, efficient EU depot operations, and reliable shipment through our trusted logistics partner.
• Secure Sample Storage: We provide secure storage for both retention and reference samples, maintaining the integrity of your product records.
• Qualified Person (QP) Declarations: Our certified Qualified Persons issue necessary declarations for both Investigational Medicinal Products (IMPs) and marketed products, guaranteeing compliance with EU regulations.
• Comprehensive Supply Chain Audits: In collaboration with our EU-GMP compliant partner, we conduct thorough audits of your manufacturing supply chain to ensure adherence to the highest quality standards.
• Effective Quality Agreement Management: We oversee the management of quality agreements, ensuring clear roles, responsibilities, and adherence to quality standards throughout the product lifecycle.
• Meticulous Shipping Document Review: We meticulously review all shipping documents and verify compliance with specified transport conditions, safeguarding product quality during transit.
• Robust Deviation and CAPA Management: We expertly manage processes related to out-of-specification results, change control procedures, deviations, and the implementation of effective Corrective and Preventive Actions (CAPAs).
• Thorough Batch Record Review: Our team conducts comprehensive reviews of batch manufacturing and packaging records to ensure accuracy and compliance.
• Compliant Batch Release: We release your batches strictly in accordance with the requirements outlined in your Marketing Authorization, facilitating timely market access.