Long Island Bio IndustriesAll Four interrelated BioTech Industries are important on Long Island
All four industry segments are monitored by the FDA and are intended to ship Safe and Effective products that medically benefit our patients or buyers.
All are developed with a “Quality First” approach that considers and documents risks and other Quality Management System requirements.
And all have deep roots on Long Island as explained below, are served by a rich tapestry of “Supply Chain” firms qualified to serve our manufacturers and all are represented by Long Island Bio.
The Food and Drug Administration defines the Pharmaceutical as the manufacture of any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
Long Island has 63 FDA-Listed Pharmaceutical Manufacturers.
Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices — these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.
Long Island has many Nutraceutical Manufacturers including some of the largest in the US.
FDA’s definition of biotechnology is the application of biological systems and organisms to technical and industrial processes.
Long Island is and has been the source of many of the world’s seminal BioTechnology discoveries from organizations like Cold Spring Harbor Laboratories and continues to spawn firms here.
The FDA says Medical Devices are “an instrument, apparatus, implement, machine, … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, contrivance, implant, in vitro reagent, or other similar or related article”
All require a Quality Management System that conforms to FDA 820.30 in the US and ISO 13485 Internationally.
Long Island is home to 174 FDA-listed Medical Device firms as well as the birthplace of medical device technologies such as MRI and PET.