FDA Compliance 

Is your company regulated by FDA Compliance Requirements?
Are you under a deadline to meet compliance requirements?
Are you uncertain how to start this complex and confusing project? 
—No problem. 

OUR TEAM OF EXPERTS CAN HELP YOU TO ACHIEVE COMPLIANCE.

We assist clients in meeting many regulatory compliance standards, including but not limited to SOX, PCI DSS, PCI- PA-DSS, PCI- PIN- Transaction Security, HIPAA, FISMA(NIST), GLBA, SAS 70, FDA, and ISO 17799 Security Standards, and recommend guidelines to meet client-specific security requirements in a timely manner.

Our security professionals and IT Auditors can help your organization to plan, develop, deploy, and integrate all the necessary security protocols, controls, and check points, and key business processes, procedures, and best practices required to reduce, control, transfer, and eliminate all potential security threats and vulnerabilities and keep your business operations in compliance

We can be the Internal Auditor or Third-Party Auditor that validates your specific security requirements. Our certified, qualified, and experienced IT Auditors can assess your organization to evaluate its security posture and provide an unbiased Attestation and Certification letter, along with an IT Audit Summary Report, to comply with specific regulatory standards.

As our IT Auditors are certified, accredited, and recognized by ISACA, an audit governing body, our audit reports are recognized and accepted by most governmental and international agencies.
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What is FDA Compliance?

The United States Food and Drug Administration (FDA) regulates products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of humans or other animals.

FDA regulates:

• Foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture.
• Food additives.
• Infant formulas.
• Dietary supplements.
• Human drugs.
• Vaccines, blood products, and other biologics.
• Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers.
• Electronic products that give off radiation, such as microwave ovens and X-ray equipment.