Biomed Research is a consulting company specializing in guiding FDA and EU regulated medical devices and combination products (drugs/biologics) through the development and marketing approval processes.

Since its inception in 1997, BIOMED has guided numerous products through design development, preclinical and clinical testing, governmental regulatory approval, and manufacturing quality systems certification.

BIOMED’s network of strategic partners also offers engineering R&D, prototype design, development & validation, medical software development & validation, and medical writing.

BIOMED provides expert

  • regulatory strategy & submissions,
  • biotechnology project team mentoring,
  • preclinical characterization,
  • clinical research & development,
  • engineering design & development,
  • medical software development & validation,
  • manufacturing quality systems services.

BIOMED can help you

  • Meet FDA, Health Canada & EU requirements.
  • Develop a strategy for government approval.
  • Develop research protocols and manage their implementation.
  • Effectively present your research results to regulatory bodies and investors.
  • Make your product submissions and negotiate with the FDA & Notified Bodies.

Contact Us Now for more information.