DEVELOPMENT
The galenic department offers a large spectrum of services from
preliminary formulation to fully validated industrial manufacturing processes
and complete CTD technical documentation for regulatory submission.
The galenic development, the professional transfer of
products and product optimisation are some of our essential strengths.
Pharmaceutical formulations
Our development team is able to provide the following services for oral topical formulations:
Pharmaceutical formulations
Our development team is able to provide the following services for oral topical formulations:
Liquid
formulations with:
_attractive
flavours
_enhanced
stability
_use of
special containment systems (preservative-free sprays, two-component system,
blisters with inert gas, alu/alu blisters, etc.)
_pediatric
delivery formulation
Solid
formulations:
_sustained
release (enhanced control by use of micro-tabs)
_one day
delivery
_gastro
resistance
Technical capabilities
_Laboratory
for pilot batches: 1 to 10 kg under GMP conditions
_ICH
stability studies at 25, 30 and 40° C
_Analytical
method development, validation and transfer
_Industrial
scale-up knowledge (incl. process validation)
