SERVICES FOR COMPANIES
With lean Agency reviewer bandwidth and fast-moving policies, companies can’t afford stalled submissions, or fragmented vendors and handoffs.
FDA Partners delivers one integrated team to align regulatory strategy, validate clinical evidence, and audit quality systems under one roof, so you stay ready.
CORE CAPABILITIES: END-TO-END SUPPORT
Precision execution from concept to commercialization.
Pre-Submission (Q-Sub) & Pre-IND Strategy and Execution
We maximize the value of the pre-submission (Q-Sub) and pre-IND processes, and the Breakthrough Device Designation (BDD)/Accelerated Review Programs, by developing the FDA strategy and then executing end-to-end: building Target Product Profiles (TPPs) and Data Development Plans (DDPs), preparing the submission package, leading high-impact “Sprint” discussions and FDA meetings, and driving favorable FDA outcomes, documented in finalized meeting minutes.
510(k) & De Novo Execution
FDA-ready eSTAR submissions with clear predicate/novelty strategy and robust substantial equivalence rationales built to avoid preventable deficiencies and keep review timelines on track.
Leverage FDA’s Least Burdensome Approach
Smartly complete value-added activities to minimize FDA regulatory requirements and clinical burdens to secure marketing approvals.
US Market Entry
Bridging international development data (Europe/Asia) to meet stringent FDA requirements.
Regulatory Due Diligence
FDA-ready eSTAR submissions with clear predicate/novelty strategy and robust substantial equivalence rationales built to avoid preventable deficiencies and keep review timelines on track.
Clinical Evidence Strategy
We design "totality of evidence" narratives, leveraging any existing Real-World Data/Evidence (RWD/RWE) to satisfy modern evidentiary standards.
Integrated Clinical Execution:
End-to-end study design, data management, and site monitoring for clinical studies.
Inspection Readiness
We don't just help you prepare; we help you survive the audit. We conduct rigorous mock inspections (on-site + virtual) and readiness assessments for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), to ensure your data and sites are compliant.
Quality Management System Requirements (QMSR) & Compliance
We build and remediate QMSR and ISO 13485 conforming systems tailored to your stage, ensuring you are scalable and audit-ready without unnecessary burden.