Regulatory Affairs & Clinical Services

Regulatory Affairs

Define Your Product Pathway

Our regulatory experts are recognized for their well-established and strong relationships with the FDA, EMA, and market authorization agencies worldwide.

With our track record of successful regulatory submissions in diagnostics, we’ll help you determine the optimal regulatory pathway to successfully navigate the submission process. We’ll optimize your investment by focusing our regulatory and quality expertise on your specific goals. 

Quality Management 

Going Beyond the Device 

Veranex understands quality goes beyond the device itself. It includes developing an appropriate Quality Management System (QMS), implementing the system, and ensuring continuous improvements throughout the total product life cycle. With more than three decades of experience behind us, Veranex will help you achieve consistent quality compliance.

Clinical (CRO)

Demonstrate the Value of Innovation

Designing and conducting your clinical study requires expertise, from study design through execution, in order to demonstrate clinical value. We have comprehensive clinical research services encompassing clinical strategy, protocol development, study design, site selection, end-to-end clinical operations, and best-in-class support services.

Detailed Expertise & Services

FDA Services

  • U.S. Regulatory Landscape Assessments
  • U.S. Regulatory Strategies
  • Breathrough Device Designation Applications
  • Safer Technologies Program (STeP) Application
  • Digital Health Software Precertification Review
  • Prepare and Faciliate Q-Submissions 
  • Investigation Device Exemptions (IDE) 
  • Premarket Notifications 510(k)
  • De Novo Applications
  • Premarket Approval Applications (PMA)
  • Humanitarian Use Device (HUD) and Expemtion Application (HDE)
  • FDA Progress Reproting (IDE’s, HDE’s, PMA’s)
  • Complaint Processing / Medical Device Reports
  • Regulatory Compliance (QSIT, preapproval, BIMO)
  • External Standards and Guidance Maintenance 
  • FDA Interfacing (meetings and regulatory submissions)
  • FDA Etablishment Registration and Product Listing 
  • Labeling (products. IFUs, operating manuals)
  • Letter-to-File Assessment 
  • Field Actions and Recall Advisory Support
  • Regulatory Release of Products (Investigational and Commercial)
  • Regulatory Review of Marketing Materials and Website
  • State of California Food and Drug Branch (FDB) License Registration

Global Regulatory Services

  • Global Regulatory Strategies
  • European Union Medical Device Regulation 2017/745 (EU MDR) Technical Documentation
  • Clinical Evaluation Plans / Reports (CEPs/CERs)
  • Change Notice Assessment 
  • External Standards 
  • Health Canada License Support 
  • Health Canada Submissions
  • Individual Country Submissions (TGA, ANMAT, ANVISA, PMDA)
  • Labeling 
  • Field Actions and Recall Support
  • Regulatory Release of Products 
  • Regulatory Review of Marketing Materials and Website
  • Self-Certification Support
  • Vigilence and Incident Report Reporting 

Quality Management 

  • Develop Quality Mangement System (QMS)
  • Gap Assessment of Client QMS 
  • Design Control Support
  • Project Management Support
  • Risk File Management Support
  • Verification and Valdiation (V&V) Master Plans
  • Design History File (DHF) Assessment and Management
  • Technical Support for Product Testing 
  • Facility Design, Maintenance, and Transfer Support
  • Process Validation and Revalidation
  • Ongoing QMS Maintenance and Support (management of annual product reviews, CAPAs, etc.)
  • Audit Support (ISO 13485, IEC 62305, quality system inspection QSIT, preapproval inspection PAI, EU MDR, etc.)
  • Agency Inspection / Audit Preparation and Support
  • Inspection / Audit Response and Remediation 
  • Postmarket Support (complaints, medical device reporting, field actions, post-market surveillance, etc.)

Clincal (CRO) Services

Clinical Study Design

  • First-in-human
  • Early Feasibility
  • Pivotal
  • Post Approval Study (PAS)
  • Post Market Surveillance
  • Patient Registries

Clinical Documentation

  • Case Report Forms (CRFs)
  • Informed Consent
  • Ivestigational Brochures
  • Clinical Management and Safety Plans

Protocol Development

  • Clinical Strategy Evidence Planning
  • Comprehensive Literature Searches
  • Risk and Complexity Assessment
  • Trial Design Consulting
  • Biostatistics Strategy and Analysis Plan
  • Protocol Writing
  • Peer Review

Site Management Support

  • Identification / Selection / Activation / Initiation
  • Institutional Review Board (IRB) and Ethics Commitee (EC)
  • Interim Monitoring and Oversight
  • Investigator Agreement Qualification
  • Regulatory Files
  • Study Budgets
  • Training
  • Closeout

Patient Recruitment

  • Patient Identification
  • Study Marketing and Patient Advertising
  • Reporting and Updates
  • Establish Management of Safety Monitoring Boards (DSMBs)
  • Establish Clinical Event Committees (CECs)
  • Maintenance of Documents / Central Study Files
  • Investigator Meetings
  • Development of Munual of Operations
  • Data Monitoring Plan and Oversight
  • Data Management and Query Resolution
  • Reading Center and Core Lab Interface
  • Review and Classify Adverse Events (AEs)
  • Generate AE Narratives and Reporting
  • Bioresearch Monitoring (BIMO), Inspection and Preparation Support