Companion Diagnostics Regulatory Affairs


Companion Diagnostics Regulatory Affairs

In the dynamic landscape of Precision Medicine, Companion Diagnostics play a crucial role in guiding targeted therapies and improving patient outcomes.

BaxMed is here to provide comprehensive Regulatory Affairs services tailored specifically to Companion Diagnostics, ensuring compliance and facilitating market access.


Why Choose BaxMed for Companion Diagnostics Regulatory Affairs?


Our team comprises Regulatory Affairs professionals with specialised knowledge and experience in Companion Diagnostics. We understand the unique regulatory requirements and challenges associated with this rapidly evolving field.

Tailored Solutions

We recognise that Companion Diagnostics have distinct regulatory pathways. Our approach is highly customised to address the specific needs of your Companion Diagnostic devices, guiding you through the regulatory process efficiently and effectively.

Global Perspective

Changes to regulations governing Companion Diagnostics often have global implications. We stay informed about regulatory changes and requirements in key markets worldwide, ensuring your products meet compliance standards internationally.


Our Comprehensive Companion Diagnostics Regulatory Affairs Services Include:

Regulatory Strategy Development: Collaborate with us to develop a strategic regulatory plan tailored to your companion diagnostic devices. We consider factors such as intended use, technology, and target markets to devise a roadmap for regulatory success.

Pre-submission Consultation: Benefit from our expert guidance and comprehensive review to ensure your regulatory submissions are complete, accurate, and compliant with regulatory standards.

Technical File and Design Dossier Preparation: Our team assists in compiling the necessary documentation, including technical files and design dossiers, essential for regulatory submissions.

Quality System Implementation: Establish and maintain quality management systems aligned with regulatory requirements, such as ISO 13485, to ensure consistent device quality and compliance.

Regulatory Submission Support: From FDA premarket approvals to CE Mark applications, we provide support throughout the regulatory submission process, including document preparation, interaction with regulatory authorities, and response to inquiries.

Post-Market Surveillance: Implement effective post-market surveillance systems to monitor the performance and safety of your companion diagnostic devices, meeting ongoing regulatory requirements and ensuring patient safety.


Partner with BaxMed for Regulatory Excellence

Companion Diagnostics play a vital role in Personalised Medicine, and navigating the regulatory landscape is essential to bringing these innovative products to market. BaxMed Regulatory Ltd is your trusted partner in Companion Diagnostic Regulatory Affairs, providing the expertise and support you need to achieve regulatory compliance and market success.

Choose BaxMed for comprehensive Companion Diagnostic Regulatory Affairs services tailored to your specific needs. Contact us today to learn more about how we can help you navigate the regulatory pathway and bring your Companion Diagnostic devices to patients in need. Together, we’ll advance Personalised Medicine and improve patient care through regulatory excellence.


Get in touch

Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.