Formulation and Tech Transfer
Seamless Technology Transfer and Innovative Formulation Development
Technology Transfer
At Centecura Healthcare, we recognize that technology transfer is a critical phase in bringing pharmaceutical innovations to market. Our dedicated team focuses on ensuring a seamless transition of processes, from research and development to commercial production.
We utilize a structured approach that includes comprehensive risk assessments, thorough documentation, and continuous communication between all stakeholders. By leveraging our deep industry knowledge and expertise, we minimize disruptions and facilitate a smooth handover that upholds quality and compliance. Our goal is to empower clients to maximize their product potential while ensuring adherence to global standards.
Our Technology Transfer Approach
- Risk Assessments: Identifying and mitigating potential risks within the technology transfer process.
- Equivalency Study: Ensuring that transferred processes produce equivalent results across sites or facilities.
- Protocol Development: Creating detailed protocols to guide every phase of the transfer.
- Training: Providing specialized training to your staff for efficient technology transfer implementation.
- Scale Batch and Validation Batch: Executing and overseeing the transfer of processes through scale and validation batches.
- Freeze of In-process Variables and Quality Attributes: Ensuring critical parameters are defined and controlled throughout production.
- Finalization of Reports: Delivering comprehensive reports that capture the results and lessons of the transfer.
- Control Strategy: Establishing a robust control strategy to ensure long-term compliance and quality performance.
Formulation Development
Centecura Healthcare is committed to advancing formulation development through a blend of scientific expertise and innovative techniques. Our team works collaboratively with clients to create optimized formulations that not only meet regulatory requirements but also enhance product efficacy and stability.
We employ a methodical process that includes rigorous testing, stability studies, and analytical evaluations to ensure that each formulation is robust and ready for market demands.
Our Formulation Development Approach
- Pre-formulation Studies: Analysis of physical and chemical properties of APIs and excipients.
- Compatibility Studies: Assessing compatibility between active ingredients and excipients.
- Scale-Up Considerations: Designing formulations that are scalable for commercial production.
- Stability Testing: Conducting stability studies to determine shelf life.
- Cost-Effective Formulations: Balancing efficacy and safety with cost-effective excipient selection.
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Why Choose Our Services?
Initial Process Review:
Thorough analysis of formulation processes, equipment, and documentation to prepare for transfer.
Efficiency:
Streamline processes for faster delivery of products.
Error Reduction:
Reduce the risk of miscommunication and procedural errors.
