Accelerating Development through Strategic Partnerships

As Functional Service Providers, Pearl Pathways enables you to deliver the comprehensive, streamlined solutions your clients require. In this role, we serve as an extension of your team – providing extra capacity while allowing you to maintain control of the overall project. From pre-clinical and clinical CROs, CMOs, CDMOs, diagnostic laboratories, clinical sites, academic institutions, and consultants, we help navigate the complexities of life science product development.

Achieving Key Milestones

By applying our expertise across early-stage research to complex, global projects, we give you the flexibility and confidence you need to outsource specific functions and tasks to keep projects on track. Backed by decades of experience across multiple industries and market segments including a wide range of therapeutic areas, we partner with development teams to craft tailored product roadmaps. Our goal is to help you expedite timelines and realize commercial success for your clients without unplanned or unnecessary delays.

Delivering Customized Solutions

We deliver right-sized solutions. Whether you’re a small to mid-size biotech, or a renowned academic institution, we offer personalized and scalable support to meet your unique needs. We empower therapeutic developers, researchers, device manufacturers and IVD developers to realize their vision for medical innovation. Our vast experience enables you to accelerate development timelines, regardless of market complexity.

Expert Guidance for Success

Pearl Pathways deliver the right tools and expertise across the product development lifecycle. Our range of services ensures you have what you need when you need it for every stage of development.

We provide a full range of services including:

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
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Quality Compliance

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

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

• Central/Single IRB for multi-site trials
• Flexible local IRB collaboration
• Fast turnaround for human research review
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Your Path to Product Success Starts Here

Every step of your product development journey requires careful evaluation and critical decisions. But with the right expertise and customized strategies, Pearl Pathways can help you reduce unplanned challenges, achieve on-time milestones, and mitigate risk to accelerate your path to market.