Experts in Quality and Regulatory Affairs strategies for local and international regulatory agencies
Experts in all your needs
Your Quality objectives and goals are our Quality objectives and goals. We believe in making your Regulatory and Quality Affairs projects a reality, and our experts know just how to do that.
We're prepared to help you with all Design Control requirements for Class I to Class IV Medical Devices, Technical File and Regulatory Submissions. Our consulting experts are always available for all your questions, and when issues arise, we are ready to provide advice or practical assistance to help you make the most of every project.
Our consultant experts have decades of cumulative experience and is collectively responsible for hundreds of successful submissions.
We are experts in:
- Analyzing, designing, and implementing programs to meet MDSAP ISO 13485:2016 - US FDA 21 CFR, Health Canada (CMDR, SOR/98-282, Australia (TGA), Brazil (ANVISA).
- US FDA GMP/QSRs compliance to 21 CFR
- Regulatory strategy development, pre-market submissions, 513(g), De Novo submissions, 510k (eSTAR), Q-Sub and FDA review
- Development of Quality manual and Quality Management Systems
Regulatory Representation:
- US Agent for Foreign Manufacturers
- Facility Registration and product listing
- Crisis intervention to FDA audit response (483), warning letters, and product recalls
- Health Canada Incident Reporting
- Product labeling and IFU (electronic and/or hard copy) compliance development and pre-submission review
Quality Systems:
- Development and maintain Quality Management Systems tailored specifically for the company needs.
- Assist with obtaining ISO certifications.
- Conduct audits of QA systems.
- Rigorous Adverse Events management; complaint control process, market specific AE reporting requirements (corrections, removals and/or recalls).
- Rigorous Supplier Control, develop and maintain a supplier qualification and monitoring program.
- Manage and design verification system to support receiving, in-process, & final product inspection and design verification.
- Incorporated statistical analysis for all required processes from receiving to final product release.
Our Experience
At QRA Consulting, we specialize in providing comprehensive regulatory affairs and quality assurance strategies to help businesses achieve regulatory compliance in local and international markets. We have a team of experienced professionals who are experts in analyzing, designing, and implementing programs that meet MDSAP ISO 13485:2016, US FDA 21 CFR, Health Canada (CMDR, SOR/98-282), Australia (TGA), Brazil (ANVISA) and many other international regulatory agencies.
Our team of professionals is well-versed in FDA submissions and understands the importance of these submissions in the regulatory process. The US FDA is responsible for ensuring the safety, efficacy, and quality of medical devices, pharmaceuticals, biotech, and diagnostic products in the United States. Therefore, FDA submissions are critical to obtaining regulatory approval and bringing products to market.
Our regulatory affairs services include pre-market submissions, 513(g), De Novo submissions, 510k (eSTAR), Q-Sub, and FDA review. We work closely with our clients to develop a regulatory strategy that meets their specific needs and helps them achieve regulatory compliance. Our expertise in FDA submissions enables us to provide our clients with high-quality services that are tailored to their unique requirements.
We understand that the FDA submission process can be complex and time-consuming. Our team of experts is here to help simplify the process and guide our clients through each step of the way. We are committed to providing exceptional service that meets or exceeds our clients' expectations.
At QRA Consulting, we are passionate about helping our clients achieve regulatory compliance and success in their business. We take pride in our work and are dedicated to providing high-quality services that exceed industry standards. Contact us today to learn more about our FDA submission services and how we can help you bring your products to market.