We have partnered with Scendea to deliver our regulatory services.
Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Scendea was founded as a result of a management buyout of the product development and regulatory consulting function of a clinical research organisation. Our origin dates back over 20 years, with involvement in over 1,000 development programmes. Scendea has team members based in the UK, Ireland, the Netherlands and the US.
Scendea’s expert team deliver strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory to successfully guide products from early development to marketing approval. A combination of scientific excellence, industry experience and commercial awareness allow our expert team to solve complex issues associated with medicinal product development, aligned to jurisdiction-specific regulatory requirements.
PHAGE CONSULTANTS specializes in prevention and troubleshooting of phage contamination problems in various production and laboratory setups. The company offers a range of services including phage and prophage detection, facility audits and initial assessments, consultations, personnel training, and advice on bioprocess optimization and new facility development. Since its establishment in 2007, Phage Consultants has successfully completed over 150 phage prevention and troubleshooting jobs, and remains a global leader in prevention and resolution of phage-related production irregularities.
Phage prevention depends heavily on extensive and reliable sample testing – Phage Consultants offers routine testing of incoming bacterial strains and cell banks for the presence of both lytic phages and prophages, a service frequently used and highly recommended by LuinaBio.
In addition to phage prevention and troubleshooting, Phage Consultants offers assistance with all aspects of bacteriophage use in various fields including biotechnology, medicine, and food and crop protection, as well as contract phage manufacturing and phage purification services. The team of expert scientists working in state-of-the-art laboratories is led by dr. Marcin Los, an expert in the field of phage development in fermentation setups and creator of many novel, rapid bacteriophage detection methods. This extensive expertise in phage biology research allows Phage Consultants to deliver high quality results in a short time and at competitive prices.