Mission

The mission of Bay Clinical R&D Services is to provide quality assistance to pharmaceutical and biotechnology companies in the planning and execution of their drug and biologics development programs

What We Do:

We can help your organization in a variety of areas of drug development and clinical operations. In detail: • We can design a development and regulatory strategy for obtaining marketing approval in the shortest time possible o Develop a target product profile which will guide development decisions o Define the regulatory precedent and the competitive environment • Assist you in critical meetings with key regulatory agencies such as the FDA and EMA • Develop clinical protocols for all phases of clinical development o Assist you in the selection of CROs, Data Acquisition and Database vendors o Manage directly clinical studies • Write/Compile NDAs/BLAs (or selected sections thereof) • Assess your development portfolio and outline the best development pathway • Assist you in your M&A or partnering program with a comprehensive due diligence analysis on regulatory and clinical development issues of acquisition/partnering targets In addition, we can assist your organization in the following tasks: • Organize a clinical research and operations department • Provide the organizational infrastructure of such a department with: o Job Descriptions o Standard Operating Procedures (SOPs) and Best Practices Documents

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