OUR SERVICES

Essentials for a Successful Early Phase Clinical Trial.

From initial feasibility to full clinical execution, Kavon ClinReg provides the regulatory and operational expertise early-stage biotech companies need to move with speed, confidence, and clarity.

Our Capabilities Include:

Specialized Consulting & Outsourcing Expertise

A clinical program based on regulatory compliance, operational feasibility and industry best practices will help move your pipeline forward.

  • Commercialization, Regulatory and Clinical Trial Advisory Support

  • Preferred Partnership Development & Subcontracting Services

  • Global Strategy Development with Local Execution

  • Tailored Subject Matter Expert (SME) Teams

  • Strategic and Tactical Business Planning

  • Concierge-Style Engagement Model

Regulatory Strategy & Submission Support

A solid foundation of regulatory compliance with clear dosing escalation logic will help ensure shorter timelines and a “critical path” to approval.

  • Fast Track, Orphan Drug, Breakthrough Therapy & Priority Review Designations

  • Regulatory Maintenance (Amendments, Annual Reports, CMC Updates)

  • FDA Meeting & Submission Support (Pre-IND & IND, End-of-Phase 2, etc.)

  • Regulatory Due Diligence & Risk Assessment

  • US Regulatory Strategy & Guidance

  • US Agent Services

  • Strategic Protocol Development (SAD/MAD, PK/PD, DDI)

  • End-to-End Clinical Development Plans (CDPs)

  • Budget Development & Timeline Forecasting

  • Institutional Review Board (IRB) Submissions

  • Human Research Ethics Committee Support

  • Clinical Trial Site Feasibility Assessments

Clinical Development Planning

Deploying skilled clinicians will enable rapid mobilization and high-quality execution without high overhead.

Medical Writing

Concise, “regulatory-grade” medical writing is mission-critical to trial success and accelerates approvals, while building investor confidence.

  • Informed Consent Forms (ICF)

  • Clinical Study Reports (CSR)

  • Protocols & Study Synopses

  • Plain Language Summaries

  • Investigator Brochures (IB)

  • Quality Review

Compliance Consulting

Building a scalable, inspection-ready compliance framework, while balancing speed with quality, will enable confident growth and regulatory trust.

  • GCP, GMP, GLP and Pharmacovigilance (PV) Audits

  • Training Programs for Sponsors and Site Teams

  • FDA Regulatory Inspection Readiness

  • SOP Development & Gap Analyses

  • QA Systems Development

  • GCP Compliance Audits

Recruitment & Operations Support

Site quality directly influences enrollment speed and data quality. Budget over runs and time delays happen when processes are not managed properly.

  • Rapid Identification of Healthy Volunteers and Patient Populations

  • Clinical Monitoring (via vetted 1099 CTMs, CRAs, CTAs)

  • Access to High-Performing, Phase 1-Ready Sites

  • Recruitment & Retention Plan Development

  • Project Management and SOP Deployment

  • Pre-Negotiated Budgets & Contracting

“Kavon brought structure and insight to our trial planning. Every step was thoughtful, efficient, and proactive. They’ve become a trusted partner.”

— BIOTECH EXECUTIVE, KAVON CLIENT

Let’s accelerate your trial efficiently and effectively.

Schedule your personalized consultation today.