Caduceus Medical Development Ltd. (CMD) provides expert strategic guidance throughout the development and commercialisation lifcyle of innovative biomedical and pharmaceutical products, while tailoring individual programs to unique client needs. CMD helps build companies as well as establish their priorities to align with business objectives during the commercialisation and market registration process. Our goal is to maximize the efficiency of the development process by reducing unnecessary activities and workload, while identifying issues and potential solutions realtime with clear and direct communication to management. CMD is expert in facilitating interactions with regulatory agencies, venture capital groups, private investors and vendors. Each stage of the product development cycle is considered, with a targeted approach to each client and individual program needs.
Regulatory and Commercial Strategy
CMD focuses on each client program using a unique approach providing the best advice in the development and commercialisation of your biomedical or pharmaceutical product. CMDs experts provide recommendations from a wholistic perspective taking into consideration the complete data package. While CMDs team is well versed in international guidelines and regulations, we have found the application of our global expertise and knowledge provides significant value to our clients and how the rules apply to their specific technology. We have found that a "one-size-fits-all-approach" does not work for innovative technology applications. The regulatory environment is in constant flux, as new technologies are being developed. As a result the regulators are constantly revising their requiements. CMD stays up to date on the requirements, and has clear understanding of how the requirements, expectations and deliverables (data, documentation etc.) shall be met in order to convince the Agencies to authorise your product for distribution. This understanding is critical to successful negotiations with the regulatory authorities. Taking this approach, CMD provides project specific strategic advice, with attention specifically placed on our clients key objectives, while demonstrating progress in reaching the next milestone, which will ultimatley lead you to success, i.e. product approval/clearance.
CMD takes an integrated approach to product development. Team members with expertise in multiple disciplines provide our clients with proven track record for success in the delivery of services during execution of their projects. CMD has significant knowledge base in the various disciplines demanded by the regulatory agencies, specifically: strategy; preclinical/nonclinical; clinical; and manufacturing & controls and is at the forefront of CMD when advancing a client program through the regulatory process. CMD looks at all strategic regulatory factors for consideration being mindful of the ultimate goal: product approval. This may be achieved by a client, a strategic partner, or by licensing the technology.
Reliable Expertise and Leadership With Proven Track Record for Success
With an average of over 20 years each in Regulatory Affairs, Quality, Non-clincial and Clinical disciplines, CMDs team provides clients with expertise of which they know they can rely. CMD team members have been involved in the development of many of the novel technologies that have emerged on the market as well as are currently engaged in areas of high technology and innovation such cancer immunotherapy, nanotechnology, diagnostics and treatment vaccines to name but a few. With CMDs experience across more than 15 therapeutic and diagnostic areas, our clients receive high value and pragmatic advice.