Kamalpreet Arora, PhD

Kamalpreet Arora, PhD

Senior Consultant

Eleven years of research review experience working in Office of Biotechnology Products, CDER, FDA. Three years of working as Science and Standards Liaison of Biologics at United States Pharmacopeia. Extensive experience with Chemistry Manufacturing and Control (CMC) modules of biologics, biosimilars and cell/gene therapy producs; novel therapeutic modalities; pharmaceuticals, complex molecules and peptides. FDA regulary preparation and review of CMC modules of INDs/BLAs/NDAs; comparability submissions, amendments andpost-approval supplements; post-marketing commitments and annual reports.


Education

PhD Biochemistry, Punjab University, Chandigarh, India (1997)
▪ MS (Honors) Biochemistry, Punjab University, Chandigarh, India (1990)
▪ BS (Honors) Biochemistry, Punjab University, Chandigarh, India (1988)