We are a specialised consulting company with a highly experienced team in bacteriophage product development. We bring a wealth of knowledge and over 20 years of practical experience in bacteriophage research and applications.
We are dedicated to advancing the field of bacteriophage therapy and other bacteriophage-based products, providing comprehensive support from initial concept through to early commercialization steps.
We can assist your process from the very beginning with the design and execution of early research experiments to explore and determine if your research idea is ready to enter the path of product development.
We work with you to ensure the early research elements selected are suitable for the next phases saving you time and costs long-term.
Our team can offer you insights and strategic advice to streamline your product characterisation process depending on the target and desired application, avoiding common pitfalls and accelerating progress.
We help you design efficient, focused studies that target key research and practical questions like formulation, delivery and stability testing, reducing unnecessary experiments and optimising resource allocation.
We can help you navigate the development of your small scale upstream and downstream processes to make sure key parameters and contamination risks are considered, thus ensuring a seamless upscale of your manufacturing process.
Similarly, we can assist with the identification and selection of the analytical assays that will be required for testing the quality of your product. By leveraging our expertise on process and analytical development, you can ascertain that your product and production processes are ready for the next phase.
Ensuring your product is consistently produced and controlled according to quality standards can be an overwhelming task.
We can help you identify partners, facilitate smooth technology transfer from R&D to the GMP manufacturing environment, pressure test budgets and establish the correct phase appropriate processes to ensure your product will be manufactured to the highest standards of quality and compliance, ultimately saving time and reducing costs associated with process inefficiencies and regulatory setbacks.
We specialise in crafting regulatory strategies tailored to your bacteriophage products. We can advise on regulatory strategy for development and execution of process validation protocols to demonstrate reproducibility and compliance with regulatory standards, as well as performing comprehensive risk assessments to identify and address potential process failures that can delay clinical development.
We can offer assistance preparing your regulatory submissions and support your interactions with regulatory agencies.
Our goal is to ensure your clinical trials are conducted efficiently and in compliance with all regulatory requirements, ultimately facilitating the successful development of your bacteriophage-based products.
We can help you design scientifically rigorous clinical trial protocols, defining clear objectives, endpoints, inclusion/exclusion criteria, and study methodologies.
Beyond the clinical trial protocol, we offer support preparing essential clinical trial documentation (e.g investigator brochures, schedule of events, case report forms, etc) and selecting the required analytical assays for sample analysis.
