Our team of researchers develops innovative and cost-effective methods and technologies. With the support and advice of our Regulatory and Quality people, we approach your CMC issues with agility, timeliness and thoroughness.
Our services in ChemPharm development apply to Active Substances (AS) as well as to Drug Products (DP):
Formulation Development
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Bio-availability enhancement of poorly soluble drugs
Suitable market formulation development
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Formulation optimization using experimental designs (e.g. preservative system)
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Selection of suitable excipients and packaging materials
Analytical Development
- HPLC method development and optimisation
- Dissolution method development
- Development of stability-indicating methods
- Appropriate validations according to development stage
- Specification justification
Process Development
- Lab-scale and pilot-scale process development
- Evaluation and optimisation of manufacturing processes
- Process characterisation and critical step evaluation
- Evaluation of starting materials and intermediates
- Manufacturing process verification and validation
- Upscaling manufacturing technologies
- Third-party manufacturing contractor selection
- Pharmaceutical development reporting
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