Let us provide a critical piece to your product development.

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Our specialization is in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion (FDA, EMA, & ROW).

We offer tailored regulatory affairs consulting from large perspective planning to detailed implementation.

Regulatory Strategy

Identification of the right regulatory strategy for all phases of development, including regulatory pathways, designations, and filings needed to support your development.

Examples: 510k, PMA, IDE, IND, Request for Designation, Risk Determination, Expedited Pathway Designations, Orphan Drug, HUD, and more...

Product Development Planning

Generation of adaptive, risk-based development plans critical for aligning internal cross-functional teams, informing executive leadership, and engaging investors.

Examples: 6- to 24-month living development plans, Executive summaries & presentations, KOL engagement, Small Business Registration, and more...

Regultory Communication Meetings

Facilitation of effective regulatory agency engagement by identifying the appropriate meeting type, generating the briefing package/submission, assisting with pre-meeting strategy and practice, overseeing meeting logistics, and completing meeting follow ups (eg, meeting minutes and feedback responses).

Examples: Pre-Submission, Type C meeting, Scientific Advice/Protocol Assistance, SPA, and more...

Quality System Design

Design, generation, and review of Quality Management Systems to ensure a system is both compliant and appropriately meets the needs of the current phase of development.

Examples: QSR, IVDR, MDR, ISO:13485, ISO:15189, CLIA, ICH, GCP, and much more...

All regulatory affairs consulting and services can be combined with medical writing activities.

Expertise in:

  • In vitro diagnostics (IVDs)
  • Laboratory Developed Tests (LDTs)
  • Therapeutic/CDx Codevelopment
  • Biomarker hypothesis development
  • Assay validation
  • Software as a Medical Device (SaMD)
  • Pharmacodynamic endpoints
  • And more...

Therapeutic areas:

  • Oncology
  • Immuno-oncology
  • Rare diseases
  • Inflammation
  • Infectious disease

Methodology Expertise:

  • Next Generation Sequencing (NGC)
  • cell-free DNA (cfDNA)
  • Flow Cytometry
  • miRNA
  • Immunohistochemistry (IHC)
  • Digital image analysis
  • To name a few...

Ready to find out more?

Contact us today with questions or to discus your project.

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