FDA Advisory Services
Navigating the FDA regulatory process requires early alignment between laboratory operations, development, validation, and regulatory strategy. For laboratories planning to submit diagnostic products, decisions made during early development often determine review timelines and downstream risk, making regulatory assistance and strategic insights crucial.
Regulatory Strategy from Early Development Through Approval
Strategic Guidance from Development Through Approval.
Three River Oaks works with laboratories and diagnostics teams to help clarify regulatory pathways, align technical and clinical activities, and prepare for FDA interactions with confidence — reducing surprises as teams move toward submission and approval.
Regulatory Strategy & FDA Submissions
We help teams plan and execute regulatory strategies that align development, validation, and submission requirements.
- FDA pre-submission strategy and study planning
- 510(k), De Novo, PMA, and EUA submission support
- FDA meeting preparation and regulatory correspondence
FDA Compliance & Audit Readiness
We support FDA inspection and audit readiness through practical quality system and operational alignment.
- FDA audit and inspection preparation
- Quality system alignment with FDA requirements
- Facility and operational readiness review
- Staff training and SOP support for regulated operations
Analytical & Clinical Validation
We provide guidance across analytical and clinical validation activities to ensure regulatory alignment and data integrity.
- Analytical validation package development
- Clinical testing and trial planning support
- Benchtop testing and validation strategy
Assay & Product Development
We support regulated assay and product development with an emphasis on feasibility, transferability, and regulatory alignment.
- RUO assay development support
- LDT technology transfer
- Molecular diagnostics development (PCR, sequencing, extraction)
- Immunoassay development and evaluation
Commercialization & Technical Strategy
When appropriate, we help teams think through early technical and regulatory considerations that impact commercialization and scale.
- Technology evaluation and feasibility assessment
- Proof-of-concept strategy development
- Commercialization pathway planning