High-Quality Services and Expertise
Grifols Bio Supplies provides high quality HSA along with assistance and expertise to ensure the most straight forward path for product registration.
Plasma Quality: From Donor to Finished Products
Grifols Bio Supplies human serum albumin (HSA) is manufactured from plasma collected at our US-based FDA- and EMA-approved plasmapheresis centers.
Our production strictly adheres to cGMP, IQPP (Plasma Protein Therapeutic Association) standards, and additional Grifols quality requirements. Production facilities are fully compliant with US FDA and EU regulations. The resulting albumin solution is pasteurized, highly purified, and licensed under both USP and EP standards.
Experts in Worldwide Product Registration
Regulatory requirements are increasingly more stringent and consequently the process of registering biological products is particularly complex. As a manufacturer of biological products that are registered in many countries, at Grifols we offer you valuable expertise in regulatory compliance around the world.
We can offer a single human serum albumin (HSA) product that complies with the regulatory requirements of multiple health authorities, allowing our customers to streamline the regulatory process.
Let us help you overcome all obstacles standing in the way of smooth product registration around the world.
A Partner You Can Count On
Grifols expert service guarantees our commitment to support your regulatory team in achieving product registration:
- Comprehensive documentation: Providing essential documents, such as our annually updated Plasma Master File and albumin registration data, along with technical support.
- Regulatory support: Offering assistance in meetings with health authorities like the US FDA and EMA, and addressing questions related to our human serum albumin (HSA).
- Global compliance: Providing up-to-date registration and support to meet evolving country-specific requirements..
- Scalability: Leveraging our extensive network of over 300 licensed collection centers located in the US and Europe, and four fractionation plants in Clayton (North Carolina, US), Los Angeles (California, US) and Barcelona (Spain).
