Followell Compliance Consultants are experienced in the following areas of focus:
Medical Device
Drugs
Biotech
Cosmetics
Food
Contact us to find out more details, including other areas not currently listed.
Device Compliance
Medical devices are sold globally and range for simple to complex and “me too” to novel technology. The level of government regulatory requirement that must be met will vary by country and will be based on the risk to the user of the device. The higher the risk, the greater effort to comply and get to market. Regulatory and Quality support is important from device concept to device end-of-life. Regulatory and Quality are critical during device design control, change management, validations, supplier management, quality systems, registrations, submissions, and more.
Drug Compliance
Generally a medicine (drug, pharmaceutical) is used to diagnose, cure, treat, or prevent disease. In the US drugs are regulated as prescription and over-the-counter. There are often “brand name” and “generic” version. Investments are large, and timelines are lengthy to bring most new drug products to market and that is why having an actively involved Regulatory and Quality participant is important to make sure there are no surprises that would create delays or increase costs. Regulatory and Quality have input and/or responsibility for creation and maintenance of product labeling, promotion, compliant ingredient source evaluation, manufacturing oversight, submissions, annual reports, just to name a few.
Biotech
Biotech is a term used for products that are used to diagnose, cure, treat, or prevent disease but unlike a drug, include the use biological material. Some biotech product configurations need a delivery system. In these instances, the biologic may be considered a Combination product that will need to meet the additional requirements of a drug or device as applicable. Similar to devices and drugs, regulatory and quality support at each phase of development and on-market support is important to success.
Cosmetic Compliance
Cosmetics are formulated product that are used to enhance appearance. Special attention is needed to ensure advertising and promotional materials do not make “drug like” claims. A cosmetic in the US might be considered a drug in another country and a cosmetic outside the US might be regulated as a drug in the US. Support from regulatory can help define the line to walk related to how the product is regulated, the needed testing and labeling details while support from quality can help evaluate suppliers and ingredients.
Food Regulatory Compliance
The US has detailed requirements on the production, distribution, import and labeling associated with foods. Medical foods also have guidelines. Supplements do not require a submission to the FDA, but ingredients must be GRAS (Generally Recognized as Safe), labeling needs to be truthful and accurate, and product must be safe and effective. Regulatory can help navigate the gray area of these regulations and Quality support can help keep processes in a state of control.
