Advancing Diagnostic Development

As world’s health challenges continue to grow, diagnostic product development will play an increasing role in tackling both the prevention and treatment of diseases.   

Pearl Pathways is a scientifically driven, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to help IVD (in-vitro diagnostics) and CDx (companion diagnostics) companies achieve product development and commercialization goals. 

Navigating Complex Regulatory Pathways

From early feasibility studies to regulatory approval, we provide strategic expertise and planning oversight necessary to comply with FDA and EU IVDR regulatory bodies.

Our dynamic consulting experts collaborate with you from conception to commercialization. We combine quality and consistency with valuable insights to help you overcome unique and complex regulatory challenges.

Tailored Solutions for Every Stage

Diagnostics are different, and we understand the unique development challenges. Whether you’re in pre-stage commercialization, or part of a global organization, our tailored and scalable solutions optimize program execution to align with your development goals. We help you navigate validation, design, and regulatory submission to successfully achieve market approval.

Expert Guidance for Diagnostics Success

Pearl Pathways’ advisors are well-equipped to guide startup and large medical device companies through the complexities of developing and commercializing all types of medical devices, from simple Class I medical supplies, to high-risk, complex Class III implantable devices. Our team ensures you have the right tools and expertise for every stage of your product’s lifecycle. Having an expert IVD or IVDR consultant on your side to help guide key decisions at all stages is a key differentiator to ensure success.
 
Our diagnostics services include:

Regulatory

• Regulatory strategy (initial & ongoing) 
• Full-service submissions (IND, NDA, BLA, etc.) 
• eCTD publishing & submission support 
• Global health authority communications
• Clinical, Non-clinical, & CMC guidance
• Platform/technology due diligence

Quality Compliance

• GxP quality systems setup & management
• Facility, lab & vendor audits
• Validation & remediation
• CMO/CRO oversight

Clinical Services

• Full-service CRO (Phase I–IV trials)
• Medical writing (protocols, CSRs, TMFs, etc.)
• ICH/GCP & site support
• Biostatistics & data management
• Pharmacovigilance

Independent Review Board (IRB)

• Central/Single IRB for multi-site trials
• Flexible local IRB collaboration
• Fast turnaround for human research review

Your Path to in-vitro diagnostic (IVD) Market Approval Starts Here

Launching a new in-vitro diagnostic (IVD) or companion diagnostics (CDx) product in today’s fast-paced market presents significant challenges for both established global manufacturers and emerging startups. It requires a trusted partner who understands the complex process that goes beyond innovation. With Pearl Pathways by your side, we reduce risk, accelerate timelines, and help you achieve market success.