ComplianceServices

Regulatory Support

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.  

Our albumins are not only the highest quality and consistent on the market but are also supported by the most comprehensive regulatory package available. With over 35 years' of experience, our team of regulatory experts has a proven track record of successful interactions with many world-leading regulators to help you navigate regulatory hurdles no matter what stage of development or lifecycle management. Whether it be the provision of our extensive Drug Master File documents, or the creation of a bespoke regulatory package and response to agency questions, our in-house regulatory experts carefully balance regulatory requirements, scientific standards, and ethics to get you onto the market quickly and safely.  

Quality & Analytical Services

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: 

• GMP incoming-lot testing 
• Bespoke stability studies 
• Custom Certificates of Analysis  
• Method validation 
• Tailored audits

Characterization Services

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. 

ENQUIRE ABOUT ENHANCED SERVICES

Please contact bd.nottingham@Sartorius.com for any enquiries.