BioExpert International Inc.

Services

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.