Experience

EurekaReg has major client experience from the medical device, biotech and pharmaceutical industries, numerous medical startups, and other leading organizations including the American Red Cross, Kimberly Clark Corporation, the National Institutes of Health (NIH) and the Department of Defense (DOD). Our specialties include:

Medical Devices

  • FDA GXP compliance services
  • CE Mark and International regulatory services
  • International product registrations
  • ISO 9001, 13485 and 14971 compliance
  • Quality systems development and training
  • Design dossier and technical file development
  • Project management services

Strategy & Development

  • Global regulatory strategy 
  • Product development and scale-up programs
  • GAP analysis and compliance services
  • U.S. agent representation – for foreign clients
  • Staff augmentation
  • Strategic sourcing and supply chain
  • Project management
  • Validation and process engineering services

Pharmaceuticals, Vaccines & Biologics

  • Vaccine and Therapeutic CMC – development
  • IND/BLA development
  • Process development and validation service
  • Drug establishment registrations

Quality & Compliance

  • Quality manuals and quality systems implementation
  • CE Mark compliance development
  • Audit programs: (Compliance, CE Mark and CAPA verifications)
  • Corrective Action/Preventive Action (CAPA)
  • Dodd-Frank: Conflict Free Metals
  • Compliance training programs (ISO, GXP, GHTF)
  • Liaison to the FDA (Meeting preparation, submissions and FDA response)
  • Liaison to International Notified Bodies

Major Accomplishments

  • Obtained early CE Mark certification for medical device firms by upgrading quality systems and technical files.
  • Reversed FDA 483 citations and improved quality rating by clarifying issues with the FDA and pointing out FDA errors.
  • Reduced development time by 2 years and saved $2 million in production costs as project manager in charge of production for drug-device combination product.
  • Obtained clearances from FDA and notified bodies on complex IVD products in infectious disease, oncology and cardiac health by upgrading technical files and writing 510(k).
  • Upgraded technical documentation and streamlined production, for blood and tissue products. Improved relations with FDA due to Warning Letter and Consent decree status.
  • Developed Vaccine and Therapeutic regulatory strategy and documentation to for IND and BLA submissions. 
  • Developed global regulatory plans for device and biologic firms and while obtaining regulatory approvals.
  • Obtained approvals of IND submissions for drug and biologic projects in infectious disease, metabolic health, reproductive health and cardiology.
  • Developed and upgraded clinical adverse reporting system and improving reporting systems for adverse events, MDRs and unanticipated events.
  • Developed malaria vaccine at NIH by using an integrated project management system to accelerate approval process.
  • Translated foreign regulatory requirements and FDA standards into plans that were easy to implement.
  • Served as regulatory and FDA liaison on design control teams and had an excellent record of success with FDA and Notified Bodies.
  • Streamlined validation and regulatory plans to obtain product approval in Latin America, Japan, EU, Canada and U.S.