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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Welcome to the September issue of RF Quarterly, in which global regulatory experts write about the key elements of regulatory strategy throughout the product lifecycle, CMS regulatory strategy, the application of project management strategies to postapproval CMC submissions, and medical writing strategies for aligning regulatory documents with strategic goals.
4 Elements of global regulatory strategy — The basics
Neal E. Storm, DRSc, MS, MBA, RAC • Monica Batra, MS, RAC (US, CAN)
21 An introduction to regulatory strategy
Darin S. Oppenheimer, DRSc, FRAPS, RAC • Jessica L. Hale, PharmD •
Suraj Ramachandran, MS, RAC • George A. Cusatis, MS RAC
31 CMC regulatory strategy
Stephen Antonelli, PhD • Michael Craig, BSc Pharm, MPSI
42 Application of project management strategy to postapproval CMC submissions
Emily A. Rapp, RAC-US • Rebecca Imperial, PMP, RAC-Drugs
53 Medical writing strategies: Aligning regulatory documents with strategic goals
Kathryn Wekselman, PhD, RN
To contribute, email Renee Matthews, Senior Editor, at email@example.com.
For more information, see:
Guidelines for Authors • 2022 Editorial Calendar • 2023 Editorial Calendar
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