A formal submission to the United States Food and Drug Administration is a professionally frightening proposition. There is a great deal at stake: the submission can lead to permission to move forward with a drug development project, with the promise of patient improvement and corporate profits. The
submission represents the tightest of bottlenecks in that development process: delays affect every other part of the operation, leading to criticism from clinical
medical; chemistry, manufacturing, and control testing ; and all other departments. And the submission response itself is open, with blunt comments from a heartless agency widely distributed. Many a regulatory professional has lost sleep over the prospect of a major submission.
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Dr Dilpreet Singh
Dr. Dilpreet Singh is working as a Associate Professor in ISF College of Pharmacy, Moga. He is a University 2nd Rank Holder in M.Pharmacy and Qualified Graduate Pharmacy Aptitude Test (GPAT) 3 times with Merit Position. His current research interest focus on Bioavailability Enhancement of drugs including Phytochemicals using lipid based technology, Design of Experiments/Quality by Design Paradigms, Systematic Optimization. He had now published 40 publications with cumulative impact factor of 42.11 in International journal of repute and presented 11 Posters and 1 Oral presentation, out from which two got Best Poster Presentation Award. He also also gathered merit position in DL-101 General Course of Intellectual Property with 98.2 % marks, sponsored by World Intellectual Property Organization (WIPO) Geneva, Switzerland. During his multidisciplinary achievements, he got Extraordinary Achievement Award by Institute of Transgene Life Sciences in Luckhnow. He completed 18 MOOC courses in International Universities, 2 Swayam courses in UGC Platform with distinction. He also qualified CSIR-NET with all India Rank 132 and Intellectual Property Talent Search Examination (IPTSE) with distinction.
