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Regulatory & Quality

Rubix LS provides end-to-end regulatory services throughout the lifecycle from the early development stage, through submission and license approval to post-approval marketing maintenance.

Medical Device

For medical devices, from a hardware and software specific focus (outside of the Digital Health domain).

  • 510k Submissions (pre-market notifications)
  • IDE (Investigational Device Exemption)
  • HDE (Humanitarian Device Exemption)
  • De Novo Requests
  • PMA (Pre-market approvals: Annual reporting and Supplements)
  • ODE Liaison
  • Combination product (Device/Drug, Device/biologic) – through supporting STeP enrollment
  • Quality program implementation
  • And more…


Inclusive of the various forms of pharma and biopharma regulated products.

  • CMC Applications and Development
  • BLA
  • ANDA & NDA
  • IND submissions
  • Pre-RFD meeting support
  • OTC filings
  • eCTD File Submissions and Management
  • Drug Master File Development
  • Annual Submissions and Supplements
  • Combination Therapy submissions (Drug/Biologic, Biologic/Biologic)
  • Clinical & Medical Affairs technical writing
  • Clinical Trial guidance
  • And more…

Software & Other

Focusing on the emerging nature of Digital Health and the intersection of SaMD’s.

  • Algorithm security provisioning
  • Endpoint and biomarker pattern recognition
  • Software Framework Development (IMDRF)
  • Security Protocol
  • Clinical Outcome
  • AI/ML Environmental Development and Cadence (RWE/RWD)
  • CGMLP (Current Good Machine Learning Practices)
  • And more…


For originated innovations that fall outside the scope of a normal pathway such as Xenotransplantation and other focuses.

  • Source Animal Characterization
  • Qualification & Validation of Manufacturing of Harvested tissues
  • Microbio testing guidance of cross-linking tissue materials
  • Tumorigenecity models and guidance for ex-vivo considerations
  • IRB, IACUC & IBC Clinical Program GAP review
  • CLIA QMS development for Laboratory Use
  • And more….