Nitisha Pyndiah, PhD – Biotech Consulting Services
Nitisha Pyndiah, PhD is a Consultant for HartmannWillner where she provides Biotech Consulting Services to clients, including strategic support for the development of biological, biotechnological, and biosimilar products during preclinical development and throughout the product lifecycle.
Nitisha has over seven years of experience in biomedical research, biotechnology, clinical studies and biotech consulting services. Her experience was gained in international reputed institutions and through projects for major pharmaceutical companies.
Her biotech consulting services expertise includes new technologies, virology, molecular biology, microbiology, immunology (including immunogenicity), quality control, quality assurance, audits, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). She also has experience in regulatory processes and requirements; Chemistry, Manufacturing and Controls (CMC) review; scientific and regulatory gap analyses of Investigational Drug Applications (INDs) and Biologics License Applications (BLAs); preparation of Quality Overall Summaries (QOS); preparation of Module 1 documents; preparation and support for FDA meeting documents; review and submission of expedited safety adverse event reporting; Orphan Drug Designations; preclinical studies; clinical trials and pediatric regulations for the EMA and FDA. She has been involved in technical, strategic, and operational regulatory affairs of originator and biosimilar recombinant proteins, monoclonal antibodies, and vaccines. She has interacted both with the EMA and the FDA (CDER and CBER).
Nitisha obtained her BSc in Biochemistry from the University of Strasbourg (France), her MSc in Medical Molecular Biology from the University of Westminster (UK) and her PhD in Microbiology with a focus on antiviral proteins and HIV from the University of Lausanne (Switzerland). Nitisha was awarded a Distinction for her MSc and obtained a Young Investigator Award from the Conference on Retroviruses and Opportunistic Infections (CROI) during her PhD. As a member of the Regulatory Affairs Professional Society (RAPS), she attends RAPS chapter meetings and has obtained a regulatory affairs certificate in Pharmaceuticals from the RAPS. Nitisha is currently preparing for her Regulatory Affairs Certification (RAC).