Rommelag Bottelpack ® BFS Technology

Unolab has sterile monodose vial production lines. It deals in the aseptic manufacturing of products in vials ranging from 0.2 mL to 10 ml

  • Manufacturing of customer formulas– Product Transfer or Full Development service
  • Manufacturing of registers formulas under Unolab CE marking - ISO 13485 quality

Research and Development and Innovation

Product development for third parties is the strategic basis of UNOLAB

Unolab has an integrated development laboratory and a complete multidisciplinary team of professionals to develop monodose products for our customers with the utmost quality and safety

  • Development of tailored formulas
  • Development and validation of analytical methods
  • Development and validation of the manufacturing process. Scaling, Pilot batches, batches for clinical trials
  • Production of register batches (Healthcare Product, Medications)
  • Manufacturing of customer formulas. - Product Transfer or Full Development in Unolab

Regulatory Advice

The regulatory experts at UNOLAB advise on the entire product registration process, from its design to the presentation of documents to the appropriate authorities, as well as throughout the product life cycle

ICH Stability

  • ICH Climatic Zones
  • Special conditions: semi-permeable, cold storage, photo-sensitivity
  • Complete product analysis as required
  • Drafting of protocol and stability report