RG
Rajesh K Gupta
Biologics Quality & Regulatory Consultants, LLC, Biologics Consulting Group, Wyeth
0000-0003-1607-4867
Employment
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Biologics Quality & Regulatory Consultants, LLC Principal Consultant2013 - Present
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Biologics Consulting Group Senior Consultant2004 - 2006
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Wyeth1998 - 2004
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U.S. Food and Drug Administration1996 - 2013
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Massachusetts Public Health Biologics Labs1991 - 1996
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National Institutes of Health1989 - 1991
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Central Research Institute1977 - 1989
Education
Education history is unavailable.
Projects & Funding
Projects & funding information is unavailable.
Publications (72)
- Low effectiveness of influenza vaccines vis-à-vis mechanism of protection by vaccines – potential causes and recommendations to improve control of influenza Save
- The vital role of biological standardization in ensuring efficacy and safety of biological products – Historical perspectives Save
- A rapid and simple sterility test method based on solid culture medium containing blood Save
- Fifty years of advancing biologicals and beyond Save
- In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical? Save
- Lot release of vaccines by regulatory authorities and harmonization of testing requirements Save
- Role of environmental monitoring and microbiological testing during manufacture of sterile drugs and biologics Save
- A human IgG anti-Vi reference for Salmonella typhi with weight-based antibody units assigned Save
- Collaborative study report: Evaluation of the ATCC experimental mycoplasma reference strains panel prepared for comparison of NAT-based and conventional mycoplasma detection methods Save
- An outline of planned changes to USP 〈1211〉 sterilization and sterility assurance of compendial articles Save