REGULATORY

From general compliance issues, reporting requirements and product approval submissions IRC has the experience and expertise to help manufacturers navigate the often confusing maze of regulations, policies, guidelines and practices in an ever changing regulatory environment. Our ability to assess issues and provide strategic planning is both unique and effective. In serving your needs we provide value to avoid costly and sometimes irreversible mistakes.

When working on product approval submissions IRC is very sensitive to the objective in achieving commercialization in a timely manner. Our sensitivity considers your need to maintain a long term market presence. On compliance issues we help to avoid the often times serious consequences which can arise through actions imposed by the regulators.

Regulatory Services
  • Strategic Planning from Design/Development to Market
  • Product Classification Review
    • Devices
    • Drugs
    • Combination Products
  • Premarket Notification 510(k) Submissions
    • New Products
    • Product/Process Changes
    • New Intended Use
  • Premarket Approval Applications
    • New Applications
    • Supplemental Applications
  • New Drug Applications / Abbreviated New Drug Applications
    • New
    • Supplements
  • Investigational Device Exemptions
    • FDA Applications
    • "Abbreviated" Requirements
  • Investigational New Drug Applications
  • Mandatory Medical Device Reporting
    • Complaint Systems
    • Service Systems
  • Complaint Master Control System
  • Master File (DMF) Preparation and Submissions
  • Labeling and Advertising Review
  • Import/Export Approvals
  • FDA Representation/Official Correspondent
  • Compliance Crisis Management
    • Regulatory Inspections
    • FDA Warning Letters
    • Consent Decree Representation
    • Recall Strategies and Management
    • Litigation Support
  • EU MDD / AIMD / IVDMD Compliance
    • CE Mark
    • Technical Files
    • Affiliate Authorized Representative