• Consulting Services

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  • Consulting for Combination Products

    Developing a drug-device combination product for global markets requires strategy to align CMC, devices, quality systems, human factors etc.

    PDX can bring together cross-disciplinary experts with a full-lifecycle approach — embedding regulatory thinking into development planning, building compliant design control and quality systems from day one. 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

    Regulatory Planning &

    Strategy Development

    Full-lifecycle regulary plan development 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

  • End-to-end consulting for combination products

    US/EU Regulatory Consulting

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