| • |
Kilo to ton quantities:
- Synthesis of 100s of gram quantities
for pre-IND screening
- cGMP production for phase I to phase
III clinical studies
- NDA validation batches
- cGMP production for commercial quantities
after NDA approval |
| • |
Multi-scale manufacturing
from oral to parenteral use, including sterile bulk |
| • |
Multi-scale manufacturing
of regulated intermediates as well as APIs |
| • |
Particle Design |
| • |
cGMP spray drying
at all scales |
| • |
Controlled particle
size reduction using state-of-the-art technologies |
| • |
Micronization of APIs
for oral, topical, injectable and inhalation use |
| • |
Continuous assessment
of processes |
| • |
Comprehensive review
and analysis of patent opportunities |
| • |
Clinical formulations:
we can supply simple oral formulations to support customers
during clinical testing; this includes filling capsules
and providing powder in bottles |
| • |
Analytical method
development and validation |
| • |
Particle analysis |
| • |
Process validation |
| • |
Regulatory filing
for IND, NDA (either DMF or CMC sections) worldwide |
| • |
Synthesis and qualification
of reference standards and impurities |
| • |
Identification and
isolation of impurities |
| • |
Stability studies
that conform to ICH guidelines |
| • |
In-house engineering
|
About Hovione 
Process chemistry expertise
