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)
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