Regulatory Support

Our customers range from medical practitioners to biopharmaceutical development and manufacturing scientists. Meeting the needs of a diverse customer group requires understanding and competent response to each of those needs. Irvine Scientific’s quality and manufacturing systems reflect industry best practices, from product development to manufacturing of GMP products. Our commitment to regulated products ensures our practices conform thoroughly to the standards of International Regulations, International Standard Organization (ISO), and United States Food and Drug Administration (FDA).

Irvine Scientific’s media manufacturing experience provides the basis for a comprehensive approach to the validation, qualification, and certification program of the manufacturing processes, equipment, and methods utilized. Each manufacturing lot file reflects not only actual product formula and analysis, but is a confirmation that it was produced as designed and in compliance with the control systems in place. Each released product is issued with an equally important deliverable: a Certificate of Analysis representing our assurance that the product meets our standards and our customers.

Irvine Scientific has submitted Type II Drug Master Files (DMF) with the US Food & Drug Administration (FDA) for many of the cell culture products we produce. The DMFs we submit provide detailed and confidential information about our facilities, manufacturing processes, packaging, and storage of any material that is used in the manufacture of a drug substance. The purpose of the DMFs is to provide the chemistry, manufacturing, and controls information to support any investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs). Technical files are prepared and maintained for those EU distributed, Class II, and Class III medical devices that carry a CE mark. IVD products are self-certified for the CE Mark. In addition, regulatory support is provided for in-country product registrations.

Quality Systems Registrations and Certifications

  • EN ISO 13485:2012, 2000/70/EC, 2003/32/EEC
  • European Medical Device Directive (93/42/EEC)
  • In vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC)
  • Canadian Medical Device Regulation
  • FDA, Federal and State Registered