Mullis & Assoc Index

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	FDA Guidance Documents	CDER Center for Drug Evaluation and Research	OC Office of Combination Products
FDA Links	CDRH Center for Devices and Radiological Health	CBER Center for Biologics Evaluation and Research	CVM Center for Veterinary Medicine

"From Concept to Market"

Mullis & Associates, Inc.