In today’s world, it is difficult to try to get through a single day without the use of cosmetics, medical devices or drugs. This can range from anything from brushing your teeth to taking a Tylenol after a long day at work. Considering how these things have such a great importance in our everyday lives, countries have realized how necessary it is for them to be regulated. All countries have a regulatory body that is dedicated to monitoring these products before they are used by people.
The US Food and Drug Administration “is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation”. The FDA is also responsible for putting into place the regulations for the production, manufacturing, importation and marketing of these products. FDA staff and Consultants have education and training for approving drugs and medical devices within their country. If you are developing products with the intention of selling them in a market you will need to go through the FDA. This can be a lengthy and expensive process where doing it right is the only possible outcome. This is when having a great FDA consulting comes in.
It is important for consumers and manufacturers alike to understand that the standard of regulations for these types of products are very high due to the constant public use and increasing environmental concerns. With the introduction of more specialized products, such as nanomaterials, engineered chemicals and advanced polymers, it is becoming increasingly more difficult to regulate these products. This is where FDA consultants can really help your business avoid running into complications getting your product on the market.
When companies have decided that it is time to call in a consultant to assist them on making their dream product a reality, there are a few things that you should think about. It is important that whoever you hire has the real-world experience to apply their knowledge to your specific situation. It is also necessary that the person that you hire has an interest in your product and wants to see your company succeed. It is important that you feel comfortable with your consultant, in order for them to understand your goals and expectations to make sure you are all on the same page.
Product manufacturers entering the American market must pay close attention to the different regulations in regards to all the various product categories in order to expedite your product to market without unnecessary delays. Focal Point Research Inc. has been successful in this industry because we combine both scientific and regulatory knowledge into our practice. We are aware that you have unique products and you can trust our almost 30 years of experience getting new products on the market.