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Search Result "Regulatory audit"

Review Article

Audit and Compliance – Bird’s Eye on Current Indian Pharmaceutical Environment

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 4 Issue: 2 Year: 2017 Page: 114-119
Author(s): Swagat Tripathy,Parijat Pandey,Smruti Mohanty,P N Murthy,Vijayakumar Sengodan Guruswamy

Case Studies

Designing an Institutional Database for Auditing and Monitoring of Clinical Research

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 5 Issue: 1 Year: 2018 Page: 63-72
Author(s): Elizabeth B. Collins,Catherine R. Brown,Terry Smolenski,Michelle C. Stickler,Robert B. Moulden,Elizabeth Ripley

Review Article

Regulatory Requirements for Medical Devices: An Insight

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 4 Issue: 1 Year: 2017 Page: 16-25
Author(s): Onkar Bedi,Pawan Krishan,Gaaminepreet Singh

Review Article

An Overview of FDA Regulatory Requirements for Vascular Devices

Journal: Applied Drug Research, Clinical Trials and Regulatory Affairs
Volume: 8 Issue: 1 Year: 2021 Page: 53-62
Author(s): Monika Targhotra,Rohan Aggarwal,Meenakshi K. Chauhan

Editorial free to download

Editorial:Regulatory Audit and Compliance in Life Science Domain

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 4 Issue: 2 Year: 2017 Page: 85-85
Author(s): Swagat Tripathy,Harish Dureja

Medical devices regulatory aspects: a special focus on polymeric material based devices

Journal: Current Pharmaceutical Design
Volume: 21 Issue: 42 Year: 2015 Page: 6246-6259
Author(s): Radhakrishnan Sridhar,Damian Pliszka,Luo He-Kuan,Keith Hsiu Chin Lim,Seeram Ramakrishna

Review Article

An Overview on Regulatory Mechanism for Pharmaceutical Excipients in Regulated Market

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 3 Issue: 2 Year: 2016 Page: 86-94
Author(s): Zinal K. Patel,Jignesh S. Shah,Dilip G. Maheshwari

Research Article

An Audit of Interim Analyses of Randomized Controlled Trials (RCTs)Published in Three High Impact Factor Medical Journals Over a Seven-year Period (2012-2018)

Journal: Reviews on Recent Clinical Trials
Volume: 16 Issue: 4 Year: 2021 Page: 403-408
Author(s): Debdipta Bose,Renju Ravi,Nithya Gogtay,Urmila M. Thatte,Tanvi Borse

Role of Quality Management System (QMS) for Effective Regulatory Compliance

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 1 Issue: 3 Year: 2014 Page: 157-168
Author(s): Bhavani Kulkarni,Ravi Chandra Vemuri

Managing and Responding to FDA Inspections

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 2 Issue: 1 Year: 2015 Page: 33-36
Author(s): Susan Margaret Muhr Leister

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