中文

Regulatory Affairs and Strategy


dMed Regulatory Affairs and Strategy Team provides end-to-end full regulatory service with high quality and efficiency.

    Capability Highlights:

  • Rich product registration experience in MNCs with deeply understanding in China regulatory environment and regulations.
  • Strong capabilities in Regulatory strategy development and operation delivery with track records.
  • Closer interaction, communication and collaboration with Regulatory agencies in professional manner.

    • Drug:

      Regulatory affairs and strategy consultation

    • Consultation of China/US/EMA registration procedure and regulations
    • Consultation of domestic and overseas onsite inspection
    • Consultation of GMP
    • Risk identification, analysis and evaluation throughout the product registration.
    • Provide solutions of critical technical issues during the product registration.

    • Product Registration Service

      ✓ Service Scope

    • Innovation drugs(Small molecule & Large Molecule): IND/NDA
      - Clinical Trial Waiver Application / Priority Review Application
      - Orphan Drug/Pediatric Drug
    • Generic Drug Application (ANDA)
    • Generic Quality Consistency Evaluation (GQCE)
    • Reference Preparation Application
    • Joint Review and Approval of Drug Substances, Excipients, Drug packaging materials
    • Post-market Variation Submission
    • Registration Renewal

    • ✓ Service List

    • Design and optimization of the registration and development strategy
    • ICH M4 (CTD) format compiling of IND submission and NDA submission
    • Product registration documents collection and gap analysis
    • Product registration compiling, revise and quality improvement
    • Product registration document translation and QC check
    • Product registration document submission
    • Product registration related process and Generic Name, Trade Name, QC Test and Onsite inspection support
    • Provide technical support during CDE review
    • Whole process support and tracking from CDE communication meeting to the final approval.
    • Importation and exportation Application
    • Communication
      - CDE communication meeting application and support (IND and NDA)
      - Regulation interpretation, training and delivery
    • Quality Control
      - SOP compiling and implementation instruction
      - ICH regulations interpretation and implementation instruction
      - CTD / eCTD format submission documents preparation support
    • Other
      - MAH Application
      - OTC Switch Application

      Medical Device:

      Regulatory affairs and R&D strategy

    • Tactic investigation and RA strategy design among multi-area including China/ USA/EU/APAC;
    • Full life-cycle management from earlier stage to post-approval;
    • Technical relevant and regulation consulting throughout whole R&D procedures;
    • Evaluation for QMS criteria, including risk assessment and mitigation plan;
    • Local and global on-site inspections consulting, covered with self-inspection and pre-inspection.

    • Product Registration Service

      ✓ Service Scope

    • Filing and registration for domestic, import Class III-I MD (including IVD);
    • Special review / priority review application;
    • Optimization for registration strategy approaches;
    • Registration specification related QC testing handling;
    • Regulatory relevant support to clinical protocol writing and operation area;
    • Close monitor regulation reforming; Insight on RA intelligence and policy trend;
    • Proactive consulting with city, provincial and national level of HAs;
    • Post-marketing maintenance.

    • ✓ Service List

    • Documentation assessment, gap analysis and compilation; including classification identification application;
    • QC testing management in details with Pre-evaluation and draft the intended spec;
    • Set up specific SOPs and training;
    • One-package support on clinical relevant affairs, for example, HGR recording;
    • Communication meeting with CMDE for clinical application of high risk MD;
    • Support the expert consultation meeting of CMDE and experts' public demonstration meeting;
    • Filing and registration application for variations affairs, continuation of registration(renew).

298 Xiangke Road, 3/F, 301-305, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201210, China
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515
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