EU Batch Release

CEMELOG-BRS Ltd. is an independent European Batch Release Site with GMP certificate for EU compliant release of batches, manufactured outside the EU.  Cemelog-BRS Ltd. is part of Cemelog Ltd., a group of different manufacturing and logistics players, providing the possibility for tailor made, cost-effective and comprehensive solutions.

• Setup of work, data and product flow from a non-EU manufacturer to the EU-wholesaler
• Elaboration of contract details according to the requirements of the European Health Authorities
• Providing API declaration for the submission of New Product Application to the European Regulatory Authorities
• Managing Method Transfer procedures in our contracted laboratories
• Consulting about European Regulatory and Quality Assurance Compliance issues utilizing the high level of expertise of our pharmacists
• Importing and Custom clearance of bulk or finished products
• Storage of goods in a bonded warehouse
• Batch control preferable via our strategic partner in laboratory works, Wessling Hungary Ltd, which laboratory is registered in our manufacturing license
• Routine  batch testing within 10 working days
• Urgent batch testing within 5 working days
•  Pack to Order for country specific packaging, with full flexibility to satisfy market demands
• Primary & secondary packaging of solid dosage forms
• Secondary packaging of ampoules (antibiotics, cytotoxics & hormones also)
• Evaluation of batch control data given by our contracted laboratories
• Batch certification for the EU markets
• Investigation of the root cause of OOS (out of specification) analytical  results
  
  • Preparation of Batch specific variation application in case of justifiable OOS
  • Qualified Person' discretion in case of justifiable OOS
• Re-packaging in case of unacceptable deviation of the approved artwork of the packaging materials (patient leaflet, carton)
• Managing DayOne Launches according to the planned launch sequence based on patent expiry, using our logistics team for organizing our in-house solutions for
• Time critical transportation of the released batches from Hungary to the EU-customers, with
• Thermo-controlled vehicles (heated/cooled), supported by an online tracking system