In the United States the businesses who deals with manufacturing, importing, or selling products such as food, beverages, pharmaceuticals, medical devices, cosmetics, and dietary supplements must fulfil the compliance requirement by getting the FDA (Food and Drug Administration) Certification that is significant. This certification set by the FDA to protect public health ensures that products meet the safety, efficacy, and quality standards.
Getting the FDA Certification helps to builds the trust with consumers and stakeholders, serving businesses gain access to one of the largest markets in the world and also ensures compliance with U.S. laws.
FDA Certification means that a product fulfils with the regulatory guidelines and standards recognized by the U.S. Food and Drug Administration. This certification ensures that the manufacturing, labelling, and marketing processes adhere to FDA guidelines and it applies to various industries, for example- food, drugs, cosmetics, and medical devices.
Purpose of getting the FDA Certification are as follows:
The certification is needed or required in achieving business success in the U.S as FDA Certification is a regulatory obligation as well as an important factor.
Advantages of having FDA Certification:
Individuals involved in manufacturing, Businesses, importing, or selling regulated products are eligible to apply FDA Certification.
Some of the businesses that can apply are as follows:
Applicants must ensure their facilities and processes comply with FDA regulations and meet specific industry requirements.
The documents are listed below that you need to apply for FDA certification:
The documents may be a bit different in some products.
Generally, the timeline for obtaining the certification FDA takes 3 to 12 months once the application is submitted but, in some situations, it may take slightly a longer duration for example- if the application is submitted incomplete or testing duration time varies because of product evaluation or due to inspection it takes longer time if the product does not meet the requirement.
The cost for getting FDA Certification varies due to following reasons:
The total cost can vary, depending on the product type and scope of work.
If you fail to get the FDA Certificate you may face dire consequences such as:
Certilize is your trusted partner for FDA Certification, ensuring a seamless and stress-free experience.
Why partner with us?
Contact Certilize today to discuss your product and begin the FDA Certification process.
For hassle free application of FDA certificate join us and let our team take the burden of the complex process. We have experience and have capability in fulfilling the task in hand within the required time frame.
Join the U.S market with FDA certification.
Manufacturers of Food and beverage, pharmaceutical companies, manufacturers of medical device, cosmetic and personal care product companies, nutraceutical and dietary supplement producers ETC requires FDA certification.
It is valid for a year after that you have to renew it.
Yes, for products falling under U.S FDA regulatory for them FDA Certification is compulsory
Certification verifies that your product complies with FDA regulations while Registration involves listing your facility with the FDA, while
The cost varies as per the product but in most case, it ranges between 5000 dollars to 50000 dollars.
Yes, if they meet the FDA’s regulatory requirements then small businesses can apply.
You can file re-inspection after addressing the deficiencies.
It is not mandatory, but getting the FDA approval for your cosmetics can boost credibility and compliance.
Depending on the product the process can take from 3 to 12 months.
It provides access to the U.S. market, ensures regulatory compliance, builds consumer trust and give you global recognition.