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Regulatory filings

Regulatory filings

Joint support with ORTHOMEDICO

WORSO scope

  • Country-level regulatory analysis and strategy design
  • Filing-route selection (notification / registration / prior evaluation)
  • Local authority liaison, agent and language coordination
  • Label drafts and packaging development
  • Post-filing customs and distribution coordination

ORTHOMEDICO scope

  • Human trial protocol design and execution
  • Systematic reviews
  • Safety and efficacy literature surveys
  • Statistical analysis and publication
  • Full-service CRO operations

Process steps

  1. 1

    Requirement analysis

    Review target-country schemes and required evidence; assess feasibility.

  2. 2

    Evidence strategy

    Decide whether existing literature suffices or new human trials are needed; optimise cost-effectiveness.

  3. 3

    Trials and research

    ORTHOMEDICO leads the human trials and systematic reviews.

  4. 4

    Dossier drafting

    Prepare country-specific application forms and supporting documents.

  5. 5

    Authority response

    End-to-end support for Q&A, supplementary submissions and local agent coordination.