QA RA Dynamics is your trusted partner in quality assurance and regulatory affairs. With an in-depth understanding of Medical device and Pharma requirements we offer comprehensive expert solutions to help you launch your products in new markets.
Why Choose Our Quality Assurance Services?
Explore
New Device Regulatory Compliance
We provide clear insights into applicable regulatory requirements for:
- Start-up companies embarking on the development journey, seeking guidance on market selection.
- Regulatory strategy and advice on the impact your selected market might have on your development journey
Expand
Current Registrations
We offer services to assist with the registration of your Listed and Registered Medicines, Class I- III Medical devices, as well as IVD new markets including:
The United Stated through FDA listing and registration European through CE marking with your Notified Body Australia through TGA listing and registration
Quality
Develop your QMS
We design adaptable Quality Management Systems that evolve alongside your organization, ensuring compliance with regulatory standards. Our systems are crafted to support and enhance your operations, rather than burdening them with unnecessary complexity. Systems include compliance to ISO 13485 as well as 21CFR 820
Additional
Audits, Training and more....
At QA RA Dynamics, we offer a range of additional services. We can assist with
- Auditing needs: whether it is internal audits, GAP assessments. or supplier audits
- Training: Medical device and GMP training
- Support in your current QMS
- nmuller@qaradynamics.com
- Australia, Sydney NSW, 2765 QA RA Dynamics
Contact Info
Our customer service team is here to answer any questions, please use this form or contact us directly via email or phone.