Regulatory Services

Regulatory services are crucial in MedTech to ensure patient safety and product efficacy. We provide comprehensive support to help sponsors and investigators comply with the latest laws, regulations, and standards.

 

Navigating Regulations:

We ensure smooth compliance with global authorities like the FDA and EMA. We prioritize integrating regulatory details early in your device plans for a proactive approach.

 

Navigating Submissions:

New medical devices must undergo regulatory submissions to meet safety, efficacy, and quality standards before market introduction. These submissions vary by product type and region. Our services include:

 

• FDA's Pre-Submissions (Q-Sub), 

• FDA's 510(k)

• FDA Premarket Approval (PMA), 

• FDA's De Novo pathway,

• Navigating EU Medical Device Regulation (MDR)

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Navigating Compliance and Communication:

Effective communication with regulatory authorities is key to navigating the MedTech landscape. We help clients respond to queries, address deficiencies, and ensure smooth interactions with bodies like the FDA, Health Canada, and EU MDR notified bodies. Our services ensure clear, thorough, and timely communication, efficiently addressing all concerns. Key services include:

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• Deficiency Letters: We offer expert guidance in addressing deficiency letters from regulatory bodies, including identifying root causes, drafting clear responses, and implementing corrective actions for compliance.

• Regulatory Questions: We help address questions or clarifications from EU MDR notified bodies, the FDA, Health Canada, and other regulators. Our team ensures responses meet required standards, keeping approval processes on track.

• Clinical Trial Communication: For clients conducting clinical trials, effective communication with regulatory bodies is crucial for progress and compliance. Our services include:

  • Study Design Considerations: We assist clients in responding to inquiries about trial design, ensuring protocols are scientifically sound and meeting regulatory expectations.

  • Annual Progress Reports: We help prepare and submit reports to keep regulators informed of trial developments, milestones, and concerns.

  • Clinical Study Reports: We guide clients in preparing compliant Clinical Study Reports, summarizing trial design, conduct, and results to facilitate smooth submissions and approvals.

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