BIOMED provides a full range of consulting services

Services

  • Preparation of regulatory submissions (510(k), IDE, PMA, CE STED, MDLA) to governmental health authorities;
  • Regulatory due diligence audits;
  • Human clinical trials research administration and management;
  • Non-clinical laboratory test protocol development and management;
  • Presentation before FDA advisory panels;
  • GAP Audits of manufacturing facilities for conformance to:
    • FDA Quality System / Good Manufacturing Practices (QS/GMP) regulations,
    • ISO 9000 [13485: 200X] Series Quality System Standards;
  • Preparation of manufacturing SOP’s and other quality system documentation;
  • FDA Registered U.S. Agent representing foreign companies in the U.S.A.

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Skilled Professionals

  • Certified regulatory expert with 25 years experience with Class III medical devices, IVDs and combination products (drugs/biologics).
  • Mayo Clinic trained physician (medical writer) with extensive clinical trials experience.
  • Clinical monitors experienced in medical device and drug trials.
  • Biostatisticians experienced in human clinical trials data management and analysis.
  • Quality systems experts experienced in designing, documenting, training and overseeing implementation of quality systems (QSR/GMP and ISO). Certifications: RAB-CQS Principal Assessor, ASQ-CQM, and ASQ-CQE.

Serving Clients’ Needs

  • BIOMED uses a team approach to project management. Projects are actively managed so clients know the status of their project at all times.
  • BIOMED can manage client projects from design verification to market approval, or fill in when a temporary gap in technical capacity exists.

Whatever the need, BIOMED can develop a plan to help achieve your goals.

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