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1

Dumitriu, Helene I. Good drug regulatory practices: A regulatory affairs quality manual. Buffalo Grove, Ill: Interpharm Press, 1998.

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2

Society, Regulatory Affairs Professionals. Fundamentals of US regulatory affairs. 7th ed. Rockville, MD: RAPS, Regulatory Affairs Professionals Society, 2011.

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3

Fundamentals of international regulatory affairs. Rockville, Md: Regulatory Affairs Professionals Society, 2010.

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4

Society, Regulatory Affairs Professionals, ed. Fundamentals of US regulatory affairs. 8th ed. Rockville, MD: Regulatory Affairs Professionals Society, 2013.

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5

Canada. Office of Privatization and Regulatory Affairs. Information: Office of Privatization and Regulatory Affairs. Canada. S.l: s.n, 1987.

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6

Huml, Raymond A. Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-3682-9.

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7

Tobin, Jack. Medical product regulatory affairs: Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-Blackwell, 2008.

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8

Weller, Ryan. Internship with Burlington Environmental Inc. Regulatory Affairs Department, Spring 1992. Bellingham, Wash: Huxley College of Environmental Studies, Western Washington University, 1993.

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9

Regulatory management: A guide to conducting environmental affairs and minimizing liability. Chelsea, Mich: Lewis Publishers, 1991.

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10

J, Pisano Douglas, and Mantus David, eds. FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2nd ed. New York: Informa Healthcare USA, 2008.

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11

United States. Congress. Senate. Committee on Governmental Affairs. Restructuring of the Nuclear Regulatory Commission: Hearings before the Committee on Governmental Affairs, United States Senate, One Hundredth Congress, second session, April 27 and May 12, 1988. Washington: U.S. G.P.O., 1988.

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12

Peach, J. Dexter. Proposal to reorganize NRC: Statement of J. Dexter Peach, Assistant Comptroller General, Resources, Community, and Economic Development Divison, before the Committee on Governmental Affairs, United States Senate. [Washington, D.C.?]: U.S. General Accounting Office, 1988.

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13

Amending Executive Order 12866: Good governance or regulatory usurpation. Washington: U.S. G.P.O., 2007.

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14

US GOVERNMENT. California's Electricity Market: The Case of Perot Systems: Hearing Before the Subcommittee on Energy Policy, Natural Resources, and Regulatory Affair. Government Printing Office, 2003.

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15

FDA Regulatory Affairs. Taylor & Francis Group, 2014.

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16

Medical Regulatory Affairs. Taylor & Francis Group, 2022.

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17

Pisano, Douglas J., and David Mantus. FDA Regulatory Affairs. Taylor & Francis Group, 2014.

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18

Pisano, Douglas J., and David Mantus, eds. FDA Regulatory Affairs. CRC Press, 2003. http://dx.doi.org/10.1201/9780203483657.

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19

Mantus, David, and Douglas J. Pisano, eds. FDA Regulatory Affairs. CRC Press, 2014. http://dx.doi.org/10.1201/b16471.

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20

Pisano, Douglas J., and David S. Mantus, eds. FDA Regulatory Affairs. CRC Press, 2008. http://dx.doi.org/10.3109/9781420073553.

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21

Drug Regulatory Affairs. CBS Publishers & Distributors, 2020.

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22

Drug Regulatory Affairs. CBS Publishers & Distributors, 2016.

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23

undifferentiated, Jones. Statistics in Regulatory Affairs. John Wiley and Sons Ltd, 1995.

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24

Fundamentals of Regulatory Affairs. Regulatory Affairs Professional Society, 1999.

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25

Dumitriu, Helene I. Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual. Taylor & Francis Group, 1997.

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26

Pisano, Douglas J., and David Mantus. FDA Regulatory Affairs: Third Edition. Taylor & Francis Group, 2014.

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27

Fundamentals of Canadian regulatory affairs. 3rd ed. Rockville, MD: Regulatory Affairs Professionals Society, 2011.

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28

Clinical Research and Regulatory Affairs. Informa Healthcare, 2006.

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29

Fundamentals of Japanese regulatory affairs. Rockville, MD: Regulatory Affairs Professional Society, 2010.

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30

Pisano, Douglas J., and David Mantus. FDA Regulatory Affairs: Third Edition. Taylor & Francis Group, 2014.

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31

Regulatory Affairs in Pharmaceutical Industry. Elsevier Science & Technology, 2022.

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32

International Journal of Drug Regulatory Affairs. India: IJDRA Publishing Group, 2013.

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33

Jong, M. G. De. FAQs on EU Pharmaceutical Regulatory Affairs. Brookwood Medical Publications, 1998.

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34

Regulatory Affairs in the Pharmaceutical Industry. Elsevier, 2022. http://dx.doi.org/10.1016/c2019-0-04686-9.

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35

Ali, Javed, and Sanjula Baboota. Regulatory Affairs in the Pharmaceutical Industry. Elsevier Science & Technology Books, 2022.

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36

Maximilian, Hall. The BCCI affair: Spotlight on the regulators. 1992.

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37

Amato, Stephen F., and Ezzell Robert M. Jr. Regulatory Affairs for Biomaterials and Medical Devices. Elsevier Science & Technology, 2018.

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38

Regulatory Affairs for Biomaterials and Medical Devices. Elsevier, 2015. http://dx.doi.org/10.1016/c2013-0-16313-1.

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39

Nanjwade, B. K. Novel Drug Delivery Systems and Regulatory Affairs. CBS Publishers & Distributors, 2019.

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40

Committee on Foreign Relations (senate), United States Senate, and United States United States Congress. U. S. -EU Cooperation on Regulatory Affairs. Independently Published, 2019.

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41

Amato, Stephen F., and Robert M. Ezzell Jr. Regulatory Affairs for Biomaterials and Medical Devices. Elsevier Science & Technology, 2014.

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42

Regulatory Affairs for Biomaterials and Medical Devices. Woodhead Publishing, 2014.

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43

Mother Profession Mother Profession House. Never Underestimate the Power of a Regulatory Affairs Specialists: Blank Lined Notebook Gift for Regulatory Affairs Specialists Women, Friend, Girlfriend Birthday Gift/ Halloween Day Gift for Regulatory Affairs Specialists. Independently Published, 2021.

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44

Walsh, Gary, and John J. Tobin. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Wiley-VCH Verlag GmbH, 2014.

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45

Walsh, Gary, and John J. Tobin. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Wiley & Sons, Incorporated, John, 2023.

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46

Handbook of Medical Device Regulatory Affairs in Asia. Taylor & Francis Group, 2013.

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47

Wehman, Thomas C. Medical Device Industry: Global Regulatory and Compliance Affairs. CRC, 2008.

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48

Huml, Raymond A. Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. Springer London, Limited, 2012.

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49

Wong, Jack, and Raymond Tong Kaiyu. Handbook of Medical Device Regulatory Affairs in Asia. Jenny Stanford Publishing, 2013.

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50

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Wiley & Sons, Incorporated, John, 2011.

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