Began in 1963 with just 3 products and 2 employees.
What is Cook Medical?
This project was named after a Superhero.
What is Project Flash?
It is responsible for protecting public health by regulating and supervising the safety, efficacy, and quality of food, pharmaceuticals, medical devices, cosmetics, biological products......... and issues 483 letters! :-)
What is FDA?
This is the legacy number for the procedure that describes the regulatory affairs activities for obtaining product marketing authorization for Cook Incorporated.
What is QSP15?
Established in 1983 and located in West Lafayette.
What is Cook Research, Inc. (CRI)?
This project is a remediation initiative for EU and APAC regions.
What is Project ATLAS?
It is Australia’s regulatory authority for therapeutic goods, including medicines, medical devices, blood products, and biologicals.
What is TGA?
It is a recently introduced software designed to manage submissions and track registrations.
What is RIMS?
Bill and Gayle Cook led the extensive and privately funded restoration of this historical landmark in a renowned resort.
It is Gene's motto that aligns with our company values.
What is SQDC?
This regulatory agency responsible for medical device regulation in China
What is NMPA?
Is a quality system form used by Regulatory Affairs to manage and update regulatory restrictions for products in specific countries and territories. This form ensures that product releases and restrictions are accurately tracked and controlled in all markets.
What is the Regulatory Restrictions Control Form?
Proximate number of individuals employed by Cook.
What is over 10,000?
This program is focus on connecting employees to resources for education and well-being, while also creating opportunities for growth and development.
What is my Cook Pathway?
What is COFEPRIS?
This audit satisfies the regulatory requirements of Australia, Brazil, Canada, Japan, and the USA.
What is MDSAP?
This author wrote the book called "Bill Cook Story: Ready, Fire, Aim.
Who is Bob Hammel?
It is a global major program/project designed to modernize business systems, processes, and data, with the aim of increasing operating income, improving resource efficiency, and enhancing customer service.
What is Voyager?
The primary regulatory agency for medical devices in Dubai and the rest of the UAE which became the sole federal authority for medical and pharmaceutical products.
What is EDE?
What is UDI?