Custom Development and Manufacturing
PharmaZell brings extensive expertise and understanding of API development and manufacturing to support for your clinical trials and commercial requirements. We operate four cGMP/FDA inspected, state-of-the-art plants.
Our services include:
- Analytical research and development
- Process development & optimization using a broad portfolio of standard and advanced proprietary technologies
- Production from kilo-lab, pilot plants to multi-ton commercial scale
- Supply chain optimisation and continuous improvement
- Stability testing and forced degradation studies
- Regulatory project management including worldwide regulatory registration support
- Supply chain control
Quality and transparency of communication with you and within our organization are key in delivering your project. Our project managers will work closely with you to ensure project teams are aligned regarding strategies and objectives and fully informed throughout the lifecycle of the project. The project manager coordinates all activities related to your project and liaises between the different departments to ensure a smooth execution. He/She will share and manage risks and ensure your project is delivered in time quality and budget.
PharmaZell process development services are built to deliver scalable and robust synthetic routes under tight timelines. PharmaZell provides you with the appropriate solution that meets your expectations for quality, quantity and regulatory compliance. We scale up your chemistry and, if needed, we can develop and optimize alternate synthetic routes. Our process development services include:
- Chemical route selection
- Optimal process and scale-up conditions are identified using DoE (design of experiment).
- API particle control (i.e. polymorphism, tailor-made particle size distributions and crystal shape)
- HSE assessment
- Process validation
We develop and implement robust analytical methods for application in daily routine environment and for validation and transfer under GMP with the following LC-equipment: HPLC/UPLC in combination with UV, RI and ELSD-detection: GC-equipment: GC and GC-HS, GC-MS.
Intellectual Property Rights
PharmaZell has the inherent right to protect its know-how, expertise and competitive advantage including sales-figures, marketing data and business strategies.
Accordingly, PharmaZell respects and protects the intellectual property rights of third parties. Employees are trained to uphold our Intellectual Property Policy and disclosing procedures. They are obliged to protect company proprietary information, unless authorized to do so.
This obligation applies to current and former employees.