clinical trial consulting OverviewRegulatory know-how. Strategic planning.Changing regulations represent a complex environment in which to develop new therapeutics. PharmaNet/i3 has assembled an exceptional team of international regulatory and pharmaceutical experts skilled in clinical development, planning and execution, and regulatory submissions. Our team's experience with regulatory agencies on five continents covering every stage of development and type of therapeutic, from early planning to post-marketing, includes:
Strategic planning during the earliest stages of clinical development optimizes project efficiencies. PharmaNet/i3 professionals begin by understanding your objectives and goals, and then build a cohesive strategic plan for program execution. By devoting more effort early in the project, PharmaNet/i3 can help anticipate potential issues and build contingency scenarios into the plan. They develop global clinical programs to avoid duplicative steps, comply with local regulations and international standards for data and reporting, while maximizing labeling claims and geographic distribution. PharmaNet/i3 professionals can also help you better understand potential risks and formulate a proactive strategy minimizing the risks associated with you program. An important aspect of risk management is Gap Analysis; a critical component of your NDA/BLA/PMA. We can review your product development plan, evaluate whether your study design is sufficiently thorough and robust, identify potential regulatory risks, suggest corrective measures, and assess your chances for first-pass approval. Expert advice backed by direct experience — it’s just one more reason why PharmaNet/i3 regulatory and pharmaceutical experts work for you. |
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