Clinical, Regulatory & Technology Assessment
Our lifesciences associate’s team assists clients to fully prepare their products for market, with a systematic process of analysis, creative input and rigorous testing. We bring to these tasks a deep understanding and knowledge of issues related to technologies, commercialization, market access, and regulatory and clinical requirements in the US, Canada, EU and other countries.
TECHNOLOGY ASSESSMENT AND SUPPORTING DOCUMENTATION
We support the evaluation of each client’s technology based on clinical utility, scientific merit, and customer needs. We bring the technology to the candidate’s clinical populations and thoroughly assess it against existing products as well as anticipated new market entries. It is also important to establish the scientific merits of the technology through key opinion-leaders and scientific experts.
MANUFACTURING STRATEGY WITH SUPPORTING QUALITY SYSTEMS
We provide the guidance necessary to insure your manufacturing process is appropriate for your business. This might include development and/or refinement of quality support systems and other tasks associated with meeting regulatory requirements.
For start-up businesses, we can assist in developing the most appropriate and cost-effective manufacturing strategy, whether it is for internal, external or a combination of both approaches.
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For established businesses with existing manufacturing sources, either internal or external, but in need of a lower cost or more qualified option, we can help provide a better solution.
In both cases, we connect your management with manufacturers we screen and qualify, both domestically and internationally. International might be offshore, in Asia, or Eastern Europe. We have established contacts in all locations and know how to qualify new ones, if appropriate. We then work closely with a selected source to insure they meet all regulatory requirements.
REGULATORY PATHWAYS FOR US FDA CLEARANCE, OR CE Mark FOR EUROPE
We work closely with biotech/pharmaceutical, medical device and diagnostics clients to prepare regulatory submissions for FDA and/or CE Mark approvals, including IDE’s, 510(k)s, and PMAs. We bring the experience and knowledge to effectively manage the approval process by working closely with regulatory agencies.
CLINICAL DEVELOPEMENT
We can provide experienced guidance in the design of clinical trials and determination of appropriate study endpoints. This might include trial site screening and selection, ongoing trial monitoring, and coordination of results, for either US or international locations. We help to establish and fulfill the requirements to support regulatory submissions, and to develop supporting scientific publications.
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