Regulatory Path Guidance & Global Filings

Streamline Your Trial from Planning through Approval

 

What Does Regulatory Strategy and Global Filing Entail?

Regulatory guidance and global filings ensure that clinical trial investigational products meet the rigorous standards of health authorities across different regions. These processes utilize strategic planning, regulatory expertise, and precise documentation to:

  • Facilitate timely approvals
  • Maintain compliance
  • Allow for the efficient progression of clinical studies from concept to market

Partner with Versiti for Trusted Regulatory Strategy

Navigate the research services regulatory landscape with confidence, relying on the expertise of Versiti Clinical Trial Services. Our knowledgeable consultants bring an average of 20 years of experience, helping you accelerate approvals, reduce costs, and bring life-changing therapies to patients.

 
 

Why Choose Versiti to Guide Your Regulatory Path?

  • Tailored Global Regulatory Strategies
    Customized pathways aligned with your product type, business goals, and market strategy
  • Expert Regulatory Interactions
    Established relationships and success with FDA, EMA, PMDA, and other global health authorities
  • Accelerated Timelines
    Streamlined processes that reduce inefficiencies and the development cycle

Comprehensive Clinical Trials Regulatory Services

Strategic Planning & Pathway Mapping

  • Regulatory strategy development tailored to your risk tolerance and budget
  • Global registration plans that maximize data reuse across clinical, non-clinical, CMC, and testing data
 
 

Clinical Global Regulatory Submissions

  • IND, NDA, ANDA, CTA, MAA, BLA, IMPD
  • 505(b)(2), HUD, HDE, CE Mark, PMTA, MRTP
  • Orphan drug/device designation
  • Expanded access/compassionate use
  • Certificates of origin

eCTD & eCopy Submission Services

  • End-to-end project management and document preparation
  • Formatting, hyperlinking, publishing, and ongoing maintenance
  • Compliance with U.S., E.U., and Japan-specific requirements
 
Our eCTD Services Include End -To-End Support
 

International Expansion Case Study

Versiti partnered with an EU-based CRO to successfully expand a clinical study into Australia and the U.S. This process included:

  • Guiding regulatory strategy and IND submission
  • Facilitating IRB interactions and site communications
  • Enabling qualified site selection aligned with study logistics and timelines

Who Does Versiti Provide Regulatory and Filing Guidance For?

Our expertise in regulatory pathing and global submission filing spans the following industries:

 
Pharmaceuticals
 
Biologics
 
Diagnostics
 
Medical Devices

Accelerate Your Path with Versiti

Let us lead you to regulatory success. We’re here to guide you through every step, from preparing your first IND to managing global filings for a complex product portfolio.

Contact Us to Get Started Today
 
Clinical Trial Management
From protocol management to regulatory compliance, our clinical trial management services ensure seamless, end-to-end study support you can rely on.
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Formulation, CMC Development, Strategy Services & Oversight
Versiti Clinical Trial Services performs validation and safety testing services for IVD, medical devices, pharmaceuticals, biopharma, assays and equipment.
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Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.
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