Typeone offers consulting and support services to both companies and research institutes that intend to develop new products or therapeutic approaches, with particular regard to the translation of the product / process being developed from the laboratory to the pre-industrial scale. Moreover, it offers technical support in all the activities related to the management of clinical trials (from the preclinical phase to Phase IV), including data management, medical writing and regulatory compliance.
Based on the indications and needs of the customer, our team defines the most effective plan and strategy to obtain the required authorizations for clinical testing and marketing of the product, in accordance with the regulations and standards in force in the targeted market area(s).
Typeone also supports the customer in the creation of the Technical Dossier and in the Risk Management of the medical device, both of which are indispensable for clinical use and regulatory (e.g. CE, FDA) approval.
After sharing the idea, the intended use and the Risk Analysis of the device with the customer, our team defines and designs the entire production process, going from the identification of the raw material(s) and the determination of the acceptance criteria, to the engineering of the manufacturing steps and the in-line quality controls that guarantee the final specifications of the Device. The process is designed in compliance with the provisions of ISO 13485 and other international standards foreseen by the specific product / application.
Upon request, Typeone develops processes and plants on a pilot scale, compliant with the cGMP standards, to verify the feasibility of the idea, the reproducibility on an industrial scale and the critical manufacturing steps. These pilot systems can be used for small production campaigns devoted to in vitro and in vivo testing, and/or clinical trials.
At its facility, Typeone organizes stages and specific training courses on production design, quality systems, regulations and standards related to medical devices and cGMP productions.