R&D usluge

During the 2022. we commenced full scale R&D

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


Preformulation

Api characterization, Forced degradation, Compatibility- API and excipients, Morphology assessment…

Formulation development of generic products

Formulation development as per QbD, Early process optimization

Analytical Development

Analytical method development for starting material, Analytical methods development for drug product, Cleaning method s development, analytical methods transfer to labs…

Stability testing

Stability studies as per ICH guidelines

Scale-up and Technology transfer

Creating Technical data package, project led

Regulatory support

CMC support

All activities are performed in order to support high quality products in timely manner.

industrial

Kontakt


+381 60 790 2200

Vlajkova 199, 16000 Leskovac, SerbiaMilutina Milankovića 23, Belgrade, Serbia

info@zdravlje.co.rs