R&D SUPPORT

From Innovation to Regulatory Approvals – Driving Product Performance and Compliance

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At the Landrich Group, we support clients through the critical early stages of product development by providing strategic, regulatory-aligned R&D services. From design verification and validation planning to managing analytical and clinical studies, we help ensure your product meets the evolving expectations of the FDA and other National Competent Authorities (NCA) . Whether you're preparing for an FDA submission—including IDE, IND, or NDA—seeking EU MDR/IVDR compliance or coordinating with other NCAs, our team ensures your study plans, data and documentation are complete, compliant, and defensible for pre-market review processes and regulatory inspections.

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Services:

• Develop Design Verification & Validation (V&V) Plans, Protocols, and Reports

• Develop Clinical Plans, Protocols, and Reports

• Manage Clinical Trials and Performance Evaluations as a CRO

• Perform Quality Management System (QMS) Gap Assessments

• Support Regulatory Communications and Submissions

  • Develop Global Regulatory Plans to assure market access in multiple markets

  • Lead U.S. FDA Pre-Subs and NCA interactions

  • Prepare, compile and submit Regulatory Submissions

  • Ensure inspection readiness

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Aligned with Global Regulatory Standards:

Our services are designed to meet the requirements of:

• U.S. FDA – including design control, risk management, V&V, and submission readiness

• NCA – compliance with country-specific regulatory frameworks

• EU MDR/IVDR –  medical device and In Vitro Diagnostic (IVD) compliance

• ICH Guidelines – pharmaceutical and diagnostics harmonized GCP

• CLSI Standards – analytical and clinical performance evaluations

 

With deep expertise across regulatory frameworks and technical development, we help R&D teams turn innovative concepts into submission-ready products—ensuring quality, traceability, and global market access from start to finish.