Pharmacosmos Quality Service Agreement
Pharmacosmos’ core business focuses on delivering high-quality Dextrans for clinical use to the market. Our Dextrans are as standard provided with a Batch Release Certificate (BRC) describing analytical results and specification limits.
When services to support a client’s application of Pharmacosmos Dextran are needed, Pharmacosmos offers the Pharmacosmos Quality Service Agreement (QSA). The QSA is an annual subscription granting the client access to the following services and assistance from Pharmacosmos:
Quality Service Agreement:
• Certificate of Suitability (CEP) (for Dextran 1, 40, 60 and 70 EP)
• Letter of Access to US Drug Master File (DMF) (for USP / Pharmaceutical Quality Dextrans)
• Documentation of stability
• Letter of change notification
• Quality declarations / statements (BSE, ICH Q3D, etc.)
• Quality and Supplier Questionnaire
• Regulatory assistance (e.g. answers to regulatory authorities)
• On-site visit
• Quality System Review* (QSR) or right to access to 3rd party audit report
* The Quality System Review (QSR) is a one-day on-site meeting enabling a client to obtain assurance that Pharmacosmos Quality System is adequate and that the manufacturing process is carried out according to GMP.
Please note all services are not available for all Dextrans.
During the last couple of years the demand from our clients to provide assistance beyond supplying high-quality clinical product has intensified. We try to meet our client’s needs via this standardized Quality Service Agreements
Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM)
Pharmacosmos delivers a unique dextran quality through a production technology that completely avoids the use of organic solvents and a quality system that meets the strictest cGMP standards for human medicines
Pharmacosmos sells and ships directly to clients everywhere in the World. We deliver Pharmaceutical Quality Dextran of the highest standards, including those of the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and the Japanese Pharmacopoeia (JP).
©2018 PHARMACOSMOS A/S
This website contains information on products which is targeted to a wide range of audiences outside US and may contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. Monofer®, CosmoFer® and Uniferon® are a registered trademarks of Pharmacosmos A/S. All rights reserved.