Pharmacosmos’ combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA) reflects our core business focused on delivering high quality dextrans for clinical use. When additional services to support your specific application of our dextrans are needed, our combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA) gives you access to the following services and assistance from Pharmacosmos:
· 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)
· Right to access third party audit reports
We know the need for assistance that goes beyond supplying high-quality clinical products has intensified in recent years, and we aim to meet your needs via our standardised SSA/QSA.
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