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2020-09-25 11:07
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Thanks to our extensive experience in medical planning for multiple new drugs and access to a wealth of expert advisory resources, we can accurately obtain market intelligence on existing pharmaceutical products, understand the launch pathways for similar products, and analyze current treatment options. This helps break down information barriers, ensures that medical strategies are well-founded and traceable, and enhances their scientific rigor and adaptability.
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Writing of clinical trial protocols and supporting documents;
Preparation of registration and filing documents;
Medical report writing (in accordance with CTD requirements and ICH GCP standards);
Medical translation, etc.;
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Starting November 1, 2024, applicants for marketing authorization of innovative drugs—as well as products that have been confirmed through communication and consultation to be eligible for the priority review and approval procedure and the conditional approval procedure—will receive early-stage acceptance services.
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