• Consulting Services

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  • Consulting for Combination Products

    Developing a drug-device combination product for global markets requires strategy that aligns CMC, devices, quality systems, human factors etc. PDX brings together cross-disciplinary experts , we take a full-lifecycle approach — embedding regulatory thinking into development planning, building compliant design control and quality systems from day one. The development that is traceable, verifiable, and registrable — and a faster, lower-risk path to global approval.

  • Your Global Regulatory Pathway, Made Clear

    From Strategy to Approval — Combination Products

    Development Strategy & Regulatory Planning

    Full-lifecycle development planning, regulatory classification, and global registration pathway design tailored to target markets

    Development System & Compliance

    Design Control, QMS (21 CFR Part 4), Risk Management (ISO 14971), and Design History File (DHF), ensuring a traceable, verifiable, and registrable development process

    Regulatory Communication & Submission Support

    FDA Pre-IND / Type C / EOP2 meetings, NMPA and EU Notified Body consultations, plus IND / NDA / BLA / MAA dossier preparation including CMC and device modules, eCTD integration, and review Q&A response

  • Teammenber & Partners

    我们的专业团队致力于提供创新和可靠的HR解决方案。

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    简·杜

    首席运营官

    简在CorePath带来了丰富的运营专业知识

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    迈克尔·李

    首席技术官

    迈克尔负责CorePath的技术进步。

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    莎拉·戴维斯

    客户成功负责人

    莎拉热衷于帮助客户取得成功。

  • Teammenber & Partners

    我们的专业团队致力于提供创新和可靠的HR解决方案。

    Section image

    简·杜

    首席运营官

    简在CorePath带来了丰富的运营专业知识

    Section image

    迈克尔·李

    首席技术官

    迈克尔负责CorePath的技术进步。

    Section image

    莎拉·戴维斯

    客户成功负责人

    莎拉热衷于帮助客户取得成功。

  • 准备好建立一个蓬勃发展的团队了吗？

    今天就联系我们，转变你的团队，实现你的目标！

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