Over the last years, in addition to the development of our own products we have been engaging in joint developments with our partners. To that respect, an increasing number of products have been developed, either together with one or more partners or exclusively for the partner.
Our expertise has allowed us to form flexible collaborations to the benefit of all parties involved. Part of this shift has also been towards the development of novel formulations, taking advantage of new excipients and formulation science. This can improve product properties, such as a more favourable release profile, better stability or improvements over the originators products.
Preformulation
- Crystallinity & polymorphism
- Powder characterization
- Powder flow properties
- Solubility studies
- Dissolution
- API-Excipient, Excipient-Excipient compatibility
Formulation Development
- Compatibility Studies
- Formulation Studies
- Lab scale trials
- Scale up Feasibility Studies
- Pre-stability Studies
- Stability Studies
Process Development
- Design Space (QbD)
- In process Controls (IPCs)
- Production Validation
- Production Transferability
- Production Scale up
- Technology Transfer
Analytical Development
- Analytical Method Development
- Analytical Method Validation
- Multimedia Dissolution Studies
- Method transferability
Other studies
- Sterilization validation
- Media Fill studies
- Hold-time studies
- Filter Validation
- Extractables – Leachables
- Nitrosamine impurities
- Elemental Impurities
- Genotoxic impurities
Services
- Formulation Support
- Process Support
- Production Efficiency
- Scale up Efficiency
- Cost Efficacy
- Time Efficacy
Technology Platforms
- Microencapsulation
- Taste Masking
- Odor masking
- SMEDDS
- SEDDS
- Solid Solutions
- Modified Drug release Kinetics