"From Concept to Market"

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Specialists in Regulatory Affairs and Clinical Studies for Medical Devices and Biotechnology

Mullis & Associates, Inc.

 


Services offered by Mullis & Associates, Inc.

Regulatory Affairs
• Develop regulatory strategy
• Create product specific regulatory plans
• Conduct presubmission reviews
• Prepare Regulatory Submissions: IDEs, 510(k)s
• PMAs, INDs, NDAs, and annual reports
• Plan and coordinate FDA meetings
• Assist with FDA establishment inspections
• Help solve FDA compliance issues
• Review cGMP procedures and Quality Systems
• Assist clients with CE marking products
• Provide customized training programs

 

Clinical Affairs
• Develop clinical strategy for new products
• Prepare tactical clinical plans for new products
• Prepare tactical clinical plans for new products
• Prepare and file IDE and IND submissions
• Plan and coordinate FDA presubmissions meeting
• Review clinical study plans
• Manage or coordinate clinical studies
• Develop investigator brochures for IRBs
• Assist with writing summaries of clinical studies
• Provide oversight for clinical study monitoring
• Preparing for and respond to Bioresearch
• Monitoring audits

Management
• Identify and manage contract research organizations (CROs)
• Provide RA, QA & CA management support
• Evaluate client's RA & CA resources

Project Reviews and Due Diligence
• Review client's new product development plans
• Assists clients with evaluating new products and technologies for acquisition
• Participate in design reviews for new projects

FDA Links

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