Manufacturers requiring a HSA source need look no for further than albumin.
Albumin is an excellent choice for use in multiple areas. Primary uses include:
Speeding and Simplifying Production
Albumin is available for use as an HSA excipient in North America, South America, some European countries, and Japan. There is no need to change HSA for countries worldwide where Albumin is licensed as a therapeutic product.
Albumin meets USP specifications, and can be tested to European Pharmacopeia requirements. Additional key testing for Albumin includes:
One Source for Worldwide Distribution
With Albumin, global use can translate to savings in time and cost for your manufactured products that are distributed worldwide. There's no need to use different albumin suppliers to meet varying international regulatory requirements.
Certificates of Analysis and Compliance
Meeting the stringent requirements for FDA approval has provided Albumin with the essential Certificate of Analysis and Certificate of Compliance, another indication that Albumin can meet your needs.
Assistance in the Approval Process — A Key Benefit
Pioneer Life Sciences has the dedicated resources to assist with your development and licensing needs — whether a new formulation, an emerging therapeutic area, or simply a switch from your current HSA brand. We offer our customers:
It's All About Getting To Market
Getting your products to market is no small feat in today's highly regulated environment. Vast resources in time and funds can be required to meet the resulting demands. Pioneer Life Sciences is pleased to offer assistance in additional key development, production, and distribution needs such as:
Our wealth of experience and resources is ready to go to work for you, paving the way for your products' success.
Custom Licensing Available
Pioneer Life Sciences will support registration efforts for your product both domestically and internationally.
