activities to support Zdravlje as an independent company and a CDMO to multinationals
R&D function was established in early 1990s
with several different areas of research: Pharmaceutical products development, API synthesis, Plant extraction and Biotechnology.
Beside formulation development for generics and specialty,
from the analytical perspective we developed testing methods for both finished products and starting materials – including API, stability indicating methods, force degradation and stability studies as per ICH in our own stability chambers
We have dedicated resources
which can also be up-sized through local partnerships (e.g. Universities, research laboratories and institutions) where we have long-established relationships
Key Activities in R&D
Api characterization, Forced degradation, Compatibility- API and excipients, Morphology assessment…
Formulation development of generic products
Formulation development as per QbD, Early process optimization
Analytical method development for starting material, Analytical methods development for drug product, Cleaning method s development, analytical methods transfer to labs…
Stability studies as per ICH guidelines
Scale-up and Technology transfer
Creating Technical data package, project led
All activities are performed in order to support highquality products in timely manner.