"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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