Regulatory Affairs

photo_Stethoscope-smallLibra Medical will provide you with a comprehensive, global regulatory strategy for all classes of medical devices, IVD, and Biologics.

The regulatory affairs strategy is seamlessly integrated into the clinical  research and quality assurance strategy for a smooth execution of any program.

Libra Medical knows how to develop novel regulatory strategies. We can develop different options and discuss the risk/benefits of each alternative along with possible fallback positions.

We represent the client in interactions with the Regulatory Agencies.  We also assist clients with device listing and establishment registration.

Regulatory Affairs Strategic Planning

After a thorough review, we will develop a strategic regulatory plan tailored to your specific product.  This plan will take your business objectives and factors about markets, countries, and regulatory agencies into account.  It is the strategy that defines an efficient and effective pathway to market approval.

A comprehensive regulatory plan should address:

  • Intended use and indications for the product.
  • Key product claims.
  • Predicate devices.
  • Anticipating regulatory risks.
  • Preclinical studies.
  • Clinical studies.
  • Labeling requirements.
  • Country specific regulatory pathways.
  • Product classification in targeted countries.
  • Export requirements and/or conditions.
  • Pertinent regulatory guidance documents.
  • Standards and directives.
  • Biocompatibility testing.
  • Manufacturing sites.
  • Contingency plans.

Libra Medical can expedite your regulatory process by communicating directly with regulatory agencies, interpreting their needs and negotiating with regulatory officials.

World Wide Submissions

Libra Medical’s extensive experience allows us to provide a comprehensive, global regulatory strategy for all classes of medical devices, IVD, and Biologics.

RegulatoryAffairsRegulatory Services Offered:

  • Premarket Notification (510K)
  • Premarket Approval Application (PMA)
  • Investigational Device Exemption (IDE)
  • Humanitarian Device (HUD)
  • Master Files
  • Humanitarian Device Exemption (HDE)
  • Registration and Licensing
  • Preparation and Representation at FDA Advisory Panels and Regulatory Agency Meetings
  • Import Certificates and Registration
  • Investigational New Drub (IND)
  • New Drug Application (NDA)
  • Biologic Licensing Application (BLA)
  • Product Submission to Health Canada, EU, Australia and Japan
  • Device Registration in Other International Countries
  • Device Listing and Establishment Registration
  • MDR and Vigilance Reporting