Expert Profile
Mukesh Kumar
Regulatory Affairs and Quality Assurance, Amarex
Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.
Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA.
Trainings by Expert
How to Withstand an FDA Audit of your Facility
Category:
Drugs and Chemicals (Pharma)
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All FDA Regulated Industry
,
FDA Audit and Inspection
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Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Life Sciences
How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA
Category:
Clinical Research
,
All FDA Regulated Industry
,
FDA Audit and Inspection
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Documentation and IT
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Documentation and Policy Management
,
Lifescience process & Procedures
,
Best Practices & GXPs
,
Life Sciences
Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements
Category:
Drugs and Chemicals (Pharma)
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GMP & cGMP
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All FDA Regulated Industry
,
Food Safety Compliance
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Quality and Safety
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Food & Dietary Supplements
,
Life Sciences
Social Media and Marketing FDA Regulated Products
Category:
All FDA Regulated Industry
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Marketing and Promotion
,
Life Sciences
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Category:
Clinical Research
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GCP & Other Best Practices
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Trial Design and Management
,
Life Sciences
FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
Category:
Clinical Research
,
GCP & Other Best Practices
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Ethics, Fraud and Misconduct
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Compliance & Ethics
,
Life Sciences
Best Practices for Maintaining an IND and IDE Application with FDA
Category:
Clinical Research
,
All FDA Regulated Industry
,
GCP & Other Best Practices
,
Clinical Trial Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
Making All Data Count: FDA Acceptance of non-US Clinical Trials
Category:
Clinical Research
,
Trial Design and Management
,
Clinical Trial Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
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All FDA Regulated Industry
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Supply chain & Procurement
,
Best Practices & GXPs
,
Life Sciences
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
Category:
Clinical Research
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
