High-Quality Services & 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 originating in our US-based FDA and EMA approved plasmapheresis centers, conforming to cGMP, IQPP of the Plasma Protein Therapeutic Association (PPTA) and fulfilling additional requirements set by Grifols. Production processes and facilities are certified according to the US FDA and EU regulations. Pasteurized, high-purity albumin solution. Grifols Human Albumin is licensed according to both USP and EP requirements.
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 assist your regulatory staff in order to achieve product registration:
- Providing documentation, such as our annually updated Plasma Master File, albumin registration data and technical support
- Offering assistance in meeting with health authorities such as the US FDA and EMA, and addressing questions that might arise related to our human serum albumin (HSA)
- Up-to-date registration and assistance to comply with each country's requirements moving forward
- Scalability
- Grifols has more than 300 licensed collection centers located in the US and Europe and 4 fractionation plants located in Clayton (North Carolina, US), Los Angeles (California, US) and Barcelona (Spain)
