Eisai Inc, [26 - 98] Davis Dr, Durham, NC 27709, US

Impact Pharmaceutical Service is a leading CMC and Regulatory Affairs solutions provider for the biopharmaceutical industry, offering expertise in Chemistry, Manufacturing, and Controls (CMC) Regulatory Services, Technical Development, and Quality GxP Compliance. With a focus on patient safety and regulatory compliance, their team of experienced professionals provides comprehensive regulatory affairs services, including regulatory strategy, publishing, and global regulatory submissions. They are committed to delivering clear and concise medical writing documents that meet scientific and regulatory standards across various therapeutic areas and development phases. With a strong dedication to CMC, Impact Pharmaceutical Service guides small molecule, biologics, cell and gene therapy, and medical device innovators through the CMC process, leveraging their deep understanding and knowledge in the field. Their approach is centered on presenting information to regulators in a clear and simple manner, focusing on providing the necessary information efficiently. By implementing science and risk-based, phase-appropriate solutions, they aim to expedite drug development and ensure regulatory compliance throughout the entire process.Generated from the website

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