Pharmacy

GMP-licensed pharmacy of the Leiden University Medical Center (LUMC) is responsible for all pharmacy related activities of clinical trials at CHDR. 

CHDR can arrange receipt and storage of the study drug according to Sponsor’s instructions, assist in preparing a pharmacy manual, organize the randomization, prepare the study drug for administration and dispensing. When required, we can also assist in importing the study drug, or in QP release of study drug by the qualified person of LUMC pharmacy.

GMP certified

Pharmacy facilities include among others:

Dedicated Trial Storage

Reconstitution & Dilution

Full license:

 Non-sterile

 Sterile: terminally sterilised

 

 Sterile: aseptic production: in ATMP  /peptide GMP facility