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 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 studies from concept to market

Partner with Versiti to Develop Your Regulatory Strategy

Navigate the current regulatory landscape with confidence, relying on the expertise of Versiti Clinical Trial Services. Our knowledgeable consultants bring an average of 20 years of experience with designing global commercialization strategies, resulting in streamlined development timelines and timely market authorizations—impacting patients sooner. 

 
 

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
    Our advisors have an average of over 20 years of experience with soliciting feedback from FDA and international regulators.
  • 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

Let our experts help with authoring your next submissions to expedite your product development to the next step.  Examples of typical Versiti filings include:

  • Meeting requests or requests to solicit feedback from regulators
  • Applications for investigational studies  (e.g., IND, IDE, etc.)
  • Marketing Authorization Applications (e.g., NDA, ANDA, 510(k), PMA, etc.)
  • Requests for Designation (RFDs)
  • Orphan Designation Requests
  • Expedited review designation

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 pre-clinical development to managing global filings and more.

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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