Services for Companies

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Leverage FDA’s least burdensome approach, conducting value-added activities to minimize FDA regulatory requirements and clinical burdens to secure marketing approvals. 

• Entering the U.S. Market: For international biopharma companies entering the U.S. market, we offer targeted pathway and study design support, including regulatory/clinical strategy, RWD/RWE framing, and GCP/GMP readiness.
• Clinical Evidence Strategy: We design "totality of evidence" narratives, leveraging any existing Real-World Data/Evidence (RWD/RWE) to satisfy modern evidentiary standards.
• Pre-Submission (Q-Sub) & Pre-IND Strategy and Execution: We maximize the value of the pre-submission (Q-Sub) and pre-IND processes, and 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. 

FDA Partners offers decision-grade guidance and FDA submission support. 

• Submission Execution:  FDA-ready eSTAR submissions with clear predicate/novelty strategy and substantial equivalence rationales designed to avoid preventable deficiencies and delays. 
• Regulatory Submission Support: Preparation and review of 510(k), De Novo, PMA, IDE, IND, and other FDA submissions, including assessment of supporting evidence and identification of documentation gaps.
• FDA Deficiency Responses: Preparation of responses to FDA questions, Additional Information requests, and other deficiencies identified during regulatory review.

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. 

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.

• Integrated Clinical Execution: End-to-end study design, data management, and site monitoring for clinical studies. 
• Clinical Study Strategy: Development of clinical protocols, endpoints, and evidence plans based on regulatory requirements and study objectives.
• Clinical Evidence Assessment: Review of existing clinical data to identify gaps and determine whether additional studies or analyses are needed to support FDA submissions.

• FDA Meeting Preparation: Development of briefing packages, meeting questions, and supporting materials for FDA discussions.
• FDA Communications: Preparation of regulatory correspondence, responses to FDA feedback, and follow-up plans.
• Regulatory Issue Resolution: Assessment of clinical holds, Complete Response Letters (CRLs), submission deficiencies, and other regulatory issues, with recommendations for addressing FDA concerns.

From early assay design to commercial manufacturing, we help strengthen their methods, interpret their data, and decide what to do next. Plan the right scientific strategy, build reliable assays, and make defensible results.

• Life-Cycle Support: We provide support throughout early development, clinical development, and commercialization.
• Scientific Strategy: Define analytical strategies that reflect your product’s characteristics, program objectives, and stage of development.
• Assays & Validation: Design, optimize, and validate assays that measure the biological activity that matters for your program.
• Method Transfer & CDMO Support: Help methods perform consistently as they move between teams, sites, and instruments.
• Troubleshooting: Identify why an assay or workflow is failing and establish practical corrective actions.