EUA Consultant will help you determine if the EUA is the right path for your device. We will help you to prepare for EUA filing and help you explore the EUA filing process and meet regulatory requirements under the EUA and after the COVID-19 outbreak.
Preparation and submission of the EUA:
Implementing an Emergency Use Authorization (EUA) process can be challenging. Our team can help to determine if obtaining the EUA is an option for your medical device product. We can guide you in planning for the EUA and developing supporting documentation. This ensures that the delivery process is efficient and timely.
Post EUA documents:
EUA issuance does not imply approval or approval from the FDA. This product is permitted only in a public health emergency when the EUA is no longer in effect. You will need the appropriate FDA approval or approval to continue commercializing your product. Our team can help you determine and comply with the regulatory requirements under the EUA and after the COVID-19 outbreak, including pre-release submissions.
What is meant by CGMP?
CGMP stands for current Good Manufacturing Practices enforced by the FDA. CGMP provides a system that ensures the proper design, inspection, and control of manufacturing processes and facilities. CGMP requirements are set for flexibility. This allows each manufacturer to decide how to best implement the necessary controls by design, processing method, and scientifically correct testing procedures. The flexibility in these regulations allows companies to Use cutting-edge technology and innovative approaches to achieve higher quality through continuous improvement. However, the FDA has not issued an official GMP certification program to acknowledge full compliance. This is where third-party leaders begin their work, offering certification opportunities.
Steps to Get CGMP Certified:
It is appropriate to follow good manufacturing practices. The manufacturing facility should be CGMP certified by a leading quality organization in the pharmaceutical industry for quality control.
If you are wondering how to get a CGMP Certification, keep in mind that there are several lengthy steps involved in this process. Organizations must meet a high level of requirements through a self-assessment of standard operating procedures and comprehensive facility inspection or inspection as well as documents on CGMP. After the auditor has issued the certificate, Companies must continue demonstrating their commitment to current GMP (cGMP) standards. Getting GMP certification is beneficial to your company’s marketing and reputation. This certification also represents our continued responsibility to move forward in ensuring product quality. The GMP-certified logo on the product increases consumer confidence in the organization in the long run.