Innovation is a critical aspect of medical and pharmaceutical product development, and the U.S. Food and Drug Administration (FDA) encourages and supports such innovative products that can benefit public health. Generally, the FDA considers innovative products to be ones that represent a significant improvement over existing products in terms of safety, efficacy, or patient care. The FDA often categorizes innovative products into two broad categories: "breakthrough" and "novel.
A common understanding of what a medical device is and how the FDA defines a medical device can be different, and in fact, is quite frequently different. Properly identifying your device is extremely important for its corresponding regulatory pathway will dramatically differ. Our consultants will help you understand your device in light of the FDA regulations and will prepare you with the requirements.
Drug products need to follow their own distinctive regulatory pathways to be in compliance with FDA regulation. In general, your product will have to go through either IND (Investigational New Drug), NDA (New Drug Application), or OTC (Over-the-Counter) drug. Each of these contains its own requirements and being prepared for them is the key to be in compliance. By working closely with our consultants, you will be able to structure the most effective and fitting strategies for your product.
This is a structural system that needs to be designed and customized for each facility that is involved in a product’s design, manufacturing, distribution, labeling, storage, and more. Built on ISO 13485 and 9001--and still evolving, US FDA 21 CFR (Code of Federal Regulation) part 820 demands such a system to assure the quality of a product for consumers' safety. By teaming up with our consultants, you will be able to create, tailor, and restructure your quality system for the welfare of your company and your customers.
As more and more innovative the cosmetic industry is becoming, the requirements of the regulations for cosmetic products are getting trickier and complex. On the one hand, innovations bring a great revolution to the industry. However, on the other hand, safety becomes a serious concern. As the new regulation MoCRA (Modernization of Cosmetics Regulation Act) is on its way, all stakeholders must prepare adequately. With so much to consider, our consultants will help you to navigate through the regulations you must be in compliance with.
FOOD & BEVERAGES
Food is an essential part of living, and therefore, the FDA sets a high standard for the safety of the consumers. Hazard Analysis & Critical Control Points (HACCP) is one of the ways in which the FDA requires facilities that are involved in manufacturing, distributing, packaging, and more. Having your product labeled in compliance with the regulations is also critical in order for your consumers to avoid any harm, and you may also want to be sensitive to the ingredients that may cause allergies. Moreover, FSVP (Foreign Supplier Verification Programs) is also required for importers to make sure that their suppliers are reliable in their handling of the food. Our consultants can help you prepare and meet the requirements so that you may be in compliance.
You might have great ideas but insufficient scientific data to support such ideas to let them become real and tangible. By conducting clinical studies, you can prove your ideas to be effective, beneficial, and safe. However, how to prove them is what must be accomplished. You need to go through a lot of preparations. Starting with the design of a study, evaluation of its effectiveness and the involved risk, going through the required regulations, and more demands exhaustive and extensive resources. Our experienced consultants will join your team and help you to craft the design it takes, compile the necessary resources, and conduct the studies while having the required regulations in check.
Having the right scientific data is the key to demonstrate your product’s safety, efficiency, and effectiveness, and we can help you get this data. Products that contact physical parts of human bodies to bring about their purpose may be demanded to demonstrate its safety via biocompatibility testing whereas products that require electricity to operate to design may be required for EMC testing. Products that do not have enough data to facilitate may be required to gather data through well-designed clinical trials. There are so many ways to prove your product, and we can help you to choose the best solution fitting for your unique needs.
Navigating the intricate realm of FDA regulations can pose challenges, even for seasoned professionals. However, engaging the services of advisory consultants can alleviate the burden, streamline operations, and enhance the efficiency of your business. Beyond providing an effective regulatory strategy, an advisory consulting group offers opportunities for expansion and ultimately higher profitability. Whether you are an established business owner or embarking on a startup venture, the inclusion of an advisory consultant brings a multitude of advantages.