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Raptim Research - Regulatory Affairs

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Raptim Research
Raptim Research - Regulatory Affairs

Regulatory affairs, nowadays, are becoming complex, and to be in a position, we need to provide apt regulatory solutions and stay ahead of changing requirements in the global clinical research industry. Raptim Regulatory team can help you build a regulatory strategy, develop global clinical and regulatory plans, and execute them on your marketed product registration requirements so you can focus on research and development.

Regulatory Affairs are a fundamental component of our services portfolio. Our team works hard to maintain high quality and strict adherence to the applicable standard(s) and guidelines like ICH, FDA, EMA, Clinical, and Bio-Analytical. Throughout your drug development lifecycle, we can help you navigate complex regulatory requirements. Our Scientific and Regulatory Affairs team participates in regulatory decisions to ensure that your study meets the requirements of the appropriate authorities.

We recognize the importance of having up-to-date knowledge of the latest regulations and guidelines to provide the best consultation service with dedicated and effective liaising with various regulatory agencies that ensure higher success ratio in the Clinical Trial approval process. We have immediate access to key areas of expertise such as medical expertise, statistics, pharmacy, project management, bio analysis, and quality assurance. We work closely with our clients to ensure that regulatory submissions are produced in accordance with the milestones and milestones of clinical trials. Raptim continually reviews and assesses the best approach reflecting the current requirements.


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