New products
Zdravlje’s dedicated experts have a strong track record of delivering new products in a timely manner and are committed to guiding partners through every stage of their new product journey.
Our New Products services include the technology transfer (Tech Transfer) of existing products and development (R&D) of new products.
Tech Transfer
The Zdravlje team is committed to delivering a seamless technology transfer process with speed and quality at the forefront of our service. We leverage our deep tech transfer expertise to ensure a smooth transition of data, materials and knowledge.
Our core Tech Transfer activities include:
- Project planning and management
- Quality risk management
- Quality target product profile (QTPP)
- Analytical method transfer and validation
- Qualification of raw material manufacturers
- Definition of critical quality attributes (CQAs)
- Scale-up of critical process parameters (CPPs)
- Process validation and process performance qualification
- Stability studies
- Launch supportContinued process verification post-completion of transfer
R&D
Our R&D scientists are equipped to create a stable and effective drug product that meets desired quality standards. Our R&D activities are built on the principles of agility, versatility and a can-do-attitude.
- Technologies
- Investigational Medicinal Product
- Industrialisation
- Formulation service
- Analytical Development Services
- Validation Department Service
- Regulatory Services
- 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
- Manufacturing, Labelling, packaging and release of IMP & placebo
- Support on the preparation of the IMP dossier
- Support on design of the clinical BE study
- Manufacturing process development and critical process parameters (CPP)
- Scientific and technical support on scale-up and engineering batches
- Tech Transfer Out (if needed)
- 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
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- 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)
- Cleaning validation
- Validation manufacturing process and packaging process
- 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
How we can help?
Reach out to us and let’s discuss how we can support your pharmaceutical manufacturing needs.
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