What is the FDA?
The Food and Drug Administration (FDA) is the oldest comprehensive federal agency responsible for consumer protection. It is a part of the United States Department of Health and Human Services.
The agency exercises authority for conducting inspections of facilities in foreign countries that supply food and pharmaceutical products to the US. Therefore, it is essential for the food and pharmaceutical plants in all these countries that export to the US to adhere well to the CGMP (Current Good Manufacturing Practices) as per the FDA guidelines.
Moreover, the FDA is also in charge of advancing the public health by putting in the effort to speed up innovations that make medical products more affordable, safer, and reliable.
Overview of FDA Approvals
It is imperative to make a point of the fact that FDA approval depends on the type of product that one intends to market in the US. Below are the product types that require FDA approval in the US to address the safety-related concerns:
Animal DrugsLearn More
Biological ProductsLearn More
Color and Food AdditivesLearn More
Food Additives for AnimalsLearn More
Human DrugsLearn More
Medical Products and DevicesLearn More
Why FDA Approval is Necessary?
The US is the major market for many pharmaceutical and food companies. The FDA protects and promotes public health by regulating and supervising the manufacture, import, transport, storage, and sale of all product types mentioned above. All the FDA approved products inform the public that they have been tested adequately for efficiency and safety. Without FDA approval, such products can't be marketed in the US (at least, not legally). Therefore, FDA approval is necessary for all the companies that manufacture or commercialize the product types mentioned above in the US. It is mandatory for such companies to place their products on the US market and establish their genuine identity as a supplier to the nation.
Are you looking for FDA Compliance Assistance?
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Contact us at: email@example.com
As a leading provider of FDA compliance assistance and services, KIPG has one motto in mind, i.e.,
Optimizing Business Efficiencies and Curtailing Regulatory Risks for our Clients.
We provide compliance assistance for all applicable regulatory and legal requirements associated with animal and human drugs, biological products, food additives for humans and animals, color additives in food, and medicinal products and devices.
We can help you with all aspects of FDA compliance, including mock audits and inspections, gap analysis, writing Standard Operating Procedures (SOPS), forms, reports, Form 483, and warning letter responses.
It is well known that the FDA regulatory landscape keeps changing from time to time as the agency often comes up with a new set of rules and guidance documents. However, that is nothing to worry about as the dedicated team of professionals at KIPG review every regulation thoroughly for fully understanding the FDA's expectations of the industry.
Our excellent lineup of industry-specific experts offers FDA compliance assistance and services to clients across the globe. We take immense pride in maintaining a brilliant rating from all our clients. Our services are always provided for cost-effective and reliable solutions with Strict Client Confidentiality and No Hidden Costs.
KIPG - Your Ultimate Solution to FDA Compliance Requirements
With vast knowledge and noticeable experience as a highly-efficient provider of FDA compliance assistance, KIPG offers the following services:
International Quality System Regulation (QSR)/Current Good Manufacturing Practice (CGMP) Inspections
Biomedical Monitoring (BIMO), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) Audits
Quality Assurance and Quality Control Functions
Risk Analysis and Assessment
Third Party and Vendor Audits
Due Diligence Audits
IT-Related Audits and Validation Support
*Whether you require FDA registration, labeling compliance, or detention assistance, KIPG is there at all times to assist you in all aspects!
Why Choose KIPG for FDA Compliance Assistance?
Proven Experience in the Industry
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