Regulatory compliance requirements extend throughout the full product lifecycle from development through approval, manufacturing, launch, and required post market reporting. Whether manufacturing medical devices or launching new pharmaceuticals, meeting global compliance requirements starts from the first specification draft. Fully understanding regulatory and quality compliance requires a level of insight and knowledge few organizations possess. Neglecting industry regulations can lead to significant setbacks in trying to achieve your strategic objectives.
Maetrics offers the insight needed to guide regulatory strategy across the pharmaceutical, biotech, medical device, and diagnostics industries. By partnering with Maetrics, today’s life sciences professionals receive the guidance they need to successfully manage the ever-changing regulatory requirements while simultaneously meeting business goals.
Comprehensive & Actionable Guidance for Life Sciences Organizations
Our team possesses the skill and experience to not only identify regulatory issues, but also to develop and execute customized tactics that address your quality and compliance needs, and position your organization for future success. We assess company operations, pinpoint areas requiring adjustment, and then put solutions in action. Whether you are planning a new submission, managing new regulations, or conducting a readiness assessment, Maetrics can leverage our broad knowledge of life sciences manufacturing and operational processes to devise an effective strategy. From the simple to the complex, Maetrics offers a broad level of support to include:
- 510K submissions
- EU Medical Device Regulation (MDR) Compliance
- In Vitro Diagnostic Regulation (IVDR) Compliance
- IND/NDA Submissions
- IDE/PMA Applications
- Mock Inspections
- Authoring, compiling, and remediating technical files and Design History Files (DHF)
- Development and creation of Clinical Evaluations Reporting (CER)
- CE Marking
- Full GxP and CAPA remediation strategies and implementation including for FDA 483 & warning letters
From staff augmentation, managed projects to full business process outsourcing, we will lead your organization to sustainable compliance success and help lay the groundwork for future innovation and performance.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.