Contact:+381 60 790 2200info@zdravlje.co.rs
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Contract Development

Zdravlje has executed over 50 projects on behalf of clients across various forms including solid dosage forms (immediate and modified release), injectables, semi-solids and infusion solutions. 

  • Technologies
  • Investigational Medicinal Product
  • Industrialisation
  • Formulation service
  • Analytical Development Services
  • Validation Department Service
  • Regulatory Services
Technologies
  • Wet granulation:
    • Granulation in High Shear Mixer 
    • Fluid Bed Spray Granulation
    • Aqueous & organic granulation 
  • Dry granulation
  • Roller compactor
  • Direct compression 
    • Imprinting 
    • Immediate and modified release
    • Solutions 
    • Nasal preparations
Investigational Medicinal Product
  • Manufacturing, Labelling, packaging and release of IMP & placebo 
  • Support on the preparation of the IMP dossier 
  • Support on design of the clinical BE study
Industrialisation
  • Manufacturing process development and critical process parameters (CPP) 
  • Scientific and technical support on scale-up and engineering batches 
  • Tech Transfer Out (if needed)
Formulation service
  • Formulation Development, Literature Research, Laboratory scale prototypes,
  • Packaging Development
  • Definition of QTPP and CQA, Finalization of Formula
  • Process Optimization
  • GMP scale-up Production, Filling, ICH Stability, Compatibility
Analytical Development Services
    • Pre-formulation Development Services
  • Analytical Method Development and validation for drug substance and drug product
  • Analytical Method Development and validation for impurities, related substances, and preservatives
  • Forced degradation studies
  • Comparative In Vitro Dissolution Tests
  • In vitro – In vivo studies
  • Pre-stability and ICH stability studies
  • Validation of microbiological methods
  • In vitro Release testing (IVRT)
  • ICH for zone II, IVa , IVb, US&EU, semi permeable products. Stability Chambers housing.
  • Consulting Services (eg. GAP, Training, Audit)
Validation Department Service
  • Cleaning validation
  • Validation manufacturing process and packaging process
Regulatory Services
  • Advice on regulatory registration strategy
  • Advice on CMC issues related development stages, manufacturing, quality control release testing
  • Specifications and stability of the product
  • Nitrosamines risk assessment and ICH Q3D elemental impurities
  • Toxicology assessment of NCE, PDE
  • Advice on clinical issues related to manufacturing of IMP
  • Support on the preparation of the Common Technical Dossier (CTD)
  • Support on the preparation of the Investigational Medicinal Product Dossier (IMPD)
  • Preparation of answers to Regulatory Bodies

Zdravlje

locations

Information

industrial

Contact

+381 60 790 2200
Vlajkova St. 199, 16000 Leskovac, SerbiaMilutina Milankovica Blvd. 23, Belgrade, Serbia
info@zdravlje.co.rs