Comprehensive Regulatory Strategy Development

We partner with your team to craft a regulatory strategy that not only aligns with your business objectives but also expedites your product’s journey to market. Our personalized approach ensures that every regulatory plan is specifically tailored to your program, driving efficiency and success.

Expert Regulatory Submission Preparation

Our dedicated experts streamline the preparation and submission of all necessary regulatory documents. Pre-submissions to product submissions (IDE, 510k, De novo, 513g, PMA, CE Marking, Device License and Registrations), we manage the complexities with precision, ensuring compliance with industry standards and regulations so you can maintain your focus on innovation.

Empowering Training and Education

Equip your team with the expertise they need through our targeted training programs. We offer in- depth sessions on regulatory requirements, quality management, and industry best practices, ensuring your staff are both knowledgeable and effective. By choosing Qualira, you are partnering with a team dedicated to not only meeting but exceeding industry standards, ensuring your success at every stage of the product lifecycle.

Remediation Activities

In the event of Regulatory compliance issues or quality concerns, our remediation activities offer a structured approach to addressing and resolving problems with worldwide regulatory bodies. We assist in identifying root causes, implementing corrective actions, and developing preventive measures to restore compliance and enhance quality. Our experienced team ensures that remediation processes are thorough and align with regulatory expectations.

Clinical Trial Strategy

Navigating clinical trials is essential for demonstrating the safety and efficacy of your medical devices. Our Clinical Trial Strategy services provide expert guidance on study design, regulatory submissions, and execution. We help you develop a strategic plan that optimizes trial outcomes, supports regulatory approvals, and aligns with your overall product development goals.

Quality Management System (QMS) Consulting

A robust Quality Management System is pivotal for regulatory compliance and product integrity. We provide strategic advice on QMS development, conducting audits and recommending improvements, all customized to meet your unique organizational requirements.Proactive Post-Market Compliance Stay ahead in the market with our vigilant post-market compliance services. We offer comprehensive support through ongoing surveillance, managing adverse events, monitoring regulatory changes, and facilitating timely updates to guarantee uninterrupted market access.