Regulatory Writing: An Overview vi
Robin Martin, MBA
Co-Founder
Kinetic Compliance Solutions,
LLC
Anna Mendlin, PhD
Associate Director, Regulatory
Medical Writing
Janssen Research and
Development, LLC
US
Tina O’Brien, MS, RAC
Director, Regulatory Affairs
Aroa Biosurgery, Ltd.
Auckland, New Zealand
Sharanya Ramasubramanian,
MS
Senior Regulatory and Clinical
Operations Associate
CCS Associates Inc.
US
Monica Ramchandani, MS,
PhD
Joanne Rupprecht, Esq, RAC
Director of Legal and Regulatory
Affairs
Aytu BioScience Inc.
US
Siegfried Schmitt, PhD
Vice President Technical
Parexel
UK
E. Michell Seymour, PhD, RAC
Principal Regulatory Consultant
R&D Advisors
Jiaying Shen, PhD
Director of Engineering
Merck
US
Thomas M. Schindler, PhD
Clinical Operations Corporate/
Medical Writing Europe
Boehringer Ingelheim Pharma
GmbH and Co. KG
Germany
Beth Silverstein, MS, RAC
Senior Scientific and Regulatory
Advisor
SciLucent, Inc.
US
Bertil Wagner
Associate Director
Janssen Research and
Development
US
Kathryn Wekselman, PhD, RN
Vice President Regulatory
MaxCyte, Inc.
US
RAPS also would like to thank
the following subject matter
experts for devoting their time to
reviewing and providing valuable
feedback to the authors on a vari-
ety of chapters.
Daniel Mannix, PhD, FRAPS
Vice President, Regulatory Affairs
MacroGenics, Inc.
US
Justina Orleans-Lindsay, PhD
Managing Director
Acadustri Limited
UK
Deborah Schwartz, RN, MS
Senior Director Regulatory
Affairs
Tessa Therapeutics
US
Alessandro Stella
Quality Manager
DREEM
France