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Product Development, Dossier Filling & Technology Transfer

Product Development, Dossier Preparation and Filing Services

At Thrius Pharma Expertize, we have an expert dossier preparation team that has been going beyond client expectations for many years. We can help you to fast-track your drug development process by assigning our experts who are quite adept at writing and formatting supporting documents. It could be a regulatory dossier, a quality document or a scientific report.

For many companies, dossier production is a costly and resource intensive process that takes up time away from the core business areas. The actual process of drug development can get delayed and even derail it due to the tedious work involved. Thrius Pharma Expertize is equipped to manage a comprehensive and error-free range of pharmaceutical dossier services to help structure production of the registration file.

At Thrius Pharma Expertize, we have fine-tuned the art of dossier preparation so that our clients stay ahead in the race to pushing products quickly to the market. Every step of the process, from formulation development to bioanalysis to manufacturing, the dossier is kept in mind, so that the data is always at hand.

We shall ensure that our team of experts from our dossier development team works in tandem to create the regulatory dossier along with the process of drug development. It is through this standardized method that we have managed to accelerate the process. This gives us a higher level of flexibility and adaptability through the entire course we take during dossier preparation.

Technology, Transfer and Troubleshooting

The term “Technology Transfer”, in the pharmaceutical lingo, indicates the processes required to move successfully from drug discovery to product development to clinical trials and finally to actual production or commercialization. It is also the process through which the developer makes the technology available to a manufacturer who will utilize the technology for commercial purposes. Thrius Pharma Expertize facilitates the process of technology transfer from pre - formulation studies to commercial production.

Why is technology transfer important?

1. To explain the required information to transfer move technology from Research & Development to manufacturing by using data and information collected during R & D.
2. To elucidate required information so that it is possible to transfer technology of current products between different manufacturing places.
3. To demonstrate areas of concern and specific methods for the above mentioned types of technology transfer and ensure the process of technology transfer is done smoothly.

It is important to have a professional partner like Thrius Pharma Expertize to manage technology transfer since it is highly critical for the drug discovery and development process for new pharmaceutical products. With a partner like us to manage it, the entire process becomes smooth and hassle-free. It is mostly economics that drives the decision to transfer products between manufacturing sites. This process includes:

1. Data collection
2. Data review
3. Analytical validation
4. Pilot or full-scale process batch
5. Stability set down

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