Clinical Affairs

Payers and regulatory authorities demand comprehensive evidence data and depend on expert assessments during the evaluation of applications for specialized medicines and complex therapies. Establish effective communication with key stakeholders to ensure they grasp the value that your drug offers to patients.

To achieve success, products must present compelling value narratives to all essential stakeholders, including providers, regulatory agencies, health technology assessment (HTA) bodies, payers, and patients. NovintiX can assist you in orchestrating this journey, from clinical development to a triumphant market entry and product endorsement. We accomplish this by showcasing the distinctive value and outcomes that your innovations offer and by connecting with a diverse array of stakeholders. Our expertise lies in recommending the most effective methods to convey your value proposition, ensuring it is comprehensible to all.

WHAT WE OFFER

Clinical Evaluation Report

Our clinical evaluation report services provide comprehensive assessments of medical device performance, safety, and efficacy, ensuring compliance with regulatory requirements.

Risk Assessment

We specialize in risk assessment methodologies, identifying and mitigating potential hazards associated with medical devices, enhancing safety and compliance.

Literature search

Our literature search capabilities enable in-depth research and analysis of medical literature, supporting evidence-based decision-making and regulatory compliance.

PMS Plan & Report

We offer PMS planning and reporting services to monitor product performance, safety, and customer feedback, ensuring ongoing compliance and product quality.

PMCF plan & Report

Our PMCF planning and reporting services focus on gathering clinical data post-market to assess device safety and performance, aligning with regulatory requirements.

Compliant analysis & report

We conduct compliance analysis and provide detailed reports to assess and improve regulatory compliance, helping clients meet industry standards and requirements.

We invest time and attention to fully understand your needs.

Our Success Stories

CER writing

Automated solution in Clinical Report writing for Medical Devices and IVDR products. Significant effort reduction on technical write ups, clinical evaluation report and clinical report.

Automation Expertise

Program level support provided for new automated foundry process for orthopedic medical device equipment qualification to increase the plant capacity from 750K to 1.1 Mn of products as E2E program management and contributed for Automated Process verification Engineering and computer system validation in hybrid model.

Manufacturing Efficiency

Achieved integrated Automated Manufacturing line for Orthopedic “Knees” platform products and brought lean manufacturing and productivity increase by 17% (Yield increased by 100,000 annually) for high volume products in short span of time with hybrid onsite and offshore operating model of Process verification engineering qualification.

Empower innovative solutions and provide best in class services to our customers & employees.

Clinical Affairs