The up to date 6200 square meters facility includes:
- a sterile manufacturing unit with an integrated line
of aseptic filling and a 17 square meters sublimation freeze
dryer.
- a quality control laboratory covering physico-chemical,
microbiological analysis and stability testing.
Development and Contract manufacturing services:
Focused on cytotoxics in
liquid and lyophilized forms,
Waypharm provides:
•
new technology development,
•
new forms ready to use,
•
new drug delivery system,
•
new drug development.
We ensure:
•
tailored therapy for hospitals,
•
pilot batches manufacturing,
•
clinical batches manufacturing
•
technical transfer, scale-up and
validation.
Stability Services:
We provide analytical support
to your stability study testing:
•
assay testing,
•
physical testing, impurity and
degradation product monitoring,
•
development and validation of
stability indicating assays.
We provide:
•
drugs Stability Testing under
Standards: ICH Q1AR2 et Q1F,
•
drugs packaged in semi-permeable
containers Stability Testing.
Development & Quality Control
Testing:
We complete development
service for almost every pharmaceutical form new or generic
ingredient:
•
analytical methods development,
•
analytical testing in accordance
with the E.P.
•
microbiological testing in
accordance with the E.P.
•
method development, risk
assessment, validation and technical services.
Doctor's Formulations & Patient's Therapy:
We provide manufacturing to
doctors's specifications of small batches.
