Sartorius AG services

Navigating the complex and ever-evolving regulatory landscape can be difficult. As `time to market` continues to be a challenge across the life science industry, in-depth knowledge and strategic oversight into the regulatory realm is becoming an increasingly important consideration.

For more than 25 years, Albumedix has manufactured the highest-quality recombinant human albumins available?from our commercial-scale manufacturing?facility,?operating at ICH Q7 GMP standards. Certified by the MHRA, as well as having been inspected by?other world-leading authorities, it`s safe to say we know a thing or two about upholding high quality and regulatory standards. Through our proven systems and processes, our QC, QA and validation experts are available to lessen your quality and analytical challenges by providing assistance with:

For more than three decades, Albumedix has pioneered albumin science, enabling us to experience a multitude of possibilities and benefits that albumin can provide. Simultaneously, we have learned a lot about the characterization challenges that working with and implementing  protein-based solutions can present. Are you spending valuable time developing assays to account for albumin interaction? If so, we can help! Using our extensive experience in modulating albumin to optimize performance, our technical team can work side by side with you to develop robust and reliable methods tailored to suit your application.