Contact:+381 60 790 2200info@zdravlje.co.rs
Product Development
The legacy of R&D in Zdravlje has a long history. Our Research Institute was established in early 1980s with a valuable support from the Faculty of Technology in Leskovac. A significant number of professors from this faculty were also employees of our R&D Zdravlje Institute.
R&D function was established in early 1990s with several different areas of research: Pharmaceutical products development, API synthesis, Plant extraction and Biotechnology.
- During the 2022. we commenced full scale R&D activities to support Zdravlje as an independent company and a CDMO to multinationals
- 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
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.
- Research activities were focused on several different areas: API synthesis development, Herbal API extraction, Biotechnology and Pharmaceutical and cosmetics formulation.
- R&D Zdravlje works on developing standard generic products – tablets, coated tablets, capsules, modified release tablets…
- Scope of activities includes:
- Formulation development
- Formulation scientist roles include design and perform the pre–formulation studies considering the characteristics of drug substance. Selection and Characterization of reference products for the use in development trials and Bio–equivalence studies. Conduct trails to finalize the Prototype and Process optimization for the pilot scale manufacturing. Execution of scale up/exhibit batches to identify the suitability of formulation and manufacturing process for higher scales. Compilation of Product Development Report (PDR) and Comparative Dissolution Report (CDR)
- Analytical development
- The purpose of analytical method development is to establish the identity, purity, physical characteristics, and potency of drugs, including the drug’s bioavailability and stability.
- Medical support
- Bioequivalence studies and other support for the clinical part of the dossier.
- Technical transfers
- Highly trained personnel with more than 50 transfers successfully performed with several different clients.
- Validation (both process and cleaning)
- Complete support in submission and post marketing approval period. Validation activities include both – Process and cleaning validation.
Zdravlje
locations
Information
industrial