Specialists in manufacturing semi-solids and liquids
The Bioglan facility allows us to produce clinical trial batches (phase I, II and III) as well as commercial scale batches for world-wide sales. The facility operates under GMP and is regularly inspected by the Swedish Medical Products Agency, a process which assures acceptance by all European authorities. The quality system fulfills the EU and FDA GMP (Good Manufacturing Practices) requirements as well as the ISO 13485 standard for Medical Devices.
Our manufacturing authorisation allows us to produce non-sterile semi-solid and liquid products, including clinical trial material. Manufacturing in batches from small scale (< 1 kg) to 1250 kg can be offered, and products can be filled into tubes, bottles and jars.
Also, non-GMP research and development materials can be manufactured in the laboratory part of the facility for use in early stability or validation studies and for preclinical trial studies.
We will optimise your formulation, while always keeping your development program in mind. Seamless scale-up, continuous method and process development, and validation performed by the same team as designed the formulation will assure the quality of your product and reduce cost and shorten the development time.