BioExpert International Inc.


BioExpert International Inc. offers the following consulting and other services:

  • Pharmaceutical and medical devices consultancy and registration services
  • ISO and regulatory affairs
  • Integrated management systems
  • Drugs development, scale-up batches, and packaging solutions
  • Regulatory consultations for US FDA, Health Canada, and European requirements
  • Quality system development and implementation of ISO 9001, 13485:2003, and QSR
  • Environment health and safety development and implementation of ISO 14000,ISO 18000, and ISO 22000
  • Investigational Device Exemption (IDE) applications
  • Pre-market notifications 510(K)
  • Pre-market approval (PMA) applications
  • Master Files
  • Manufacturing process specifications, process validation, sterilization, clean room, seal, and packaging for pharmaceuticals, cosmeceuticals, nutraceuticals, herbal and natural products, and food supplements
  • Installation and operation qualification and specification (I/Q, O/Q)
  • Review and development of instruction manuals and other labeling for FDA compliance
  • Product classification and essential requirements determination
  • Preparation for FDA inspections and registrar or notified body assessments
  • Assessment study, implementation and follow-up for biological evaluation of medical devices and biomaterials according to ISO 10993 standard and regulatory requirements
  • Program testing, preparation of test house planning, test house shopping and selection
  • Selection of most profitable strategic approach for optimal economical testing program
  • Liaison with FDA, the research institutes, CROs, and governmental bodies.