Antonina Nikolova, Ph.D.

Antonina Nikolova, Ph.D.

Antonina Nikolova, Ph.D.

Principal Consultant

Antonina is a Regulatory Affairs professional with over 15 years of experience in the reviewing and preparation/coordination of the CMC part for submission according to regulatory requirements of EU, USA, Canada, Japan, Emerging markets. She has experience in Establishing regulatory and scientific concepts across groups and with internal and external stakeholders. Providing regulatory CMC input and support development projects of biopharmaceutical products. Prior to joining Parexel, Antonina held a Regulatory CMC Advisor, Biosimilars, Novartis, Schaftenau, Austria for 2 years, and senior staff fellow position at FDA, CDER/OBP for over 13 years. 

Work Experience

Antonina uses her extensive scientific, drug development and regulatory experience to assist clients in the negotiation of regulatory strategies with FDA, EMA and other regulatory agencies to achieve their company objectives. She provides scientific research/consulting, engaged in discussing and reviewing findings, techniques, procedures and advances in hematology, immunology, cancer research, biological sciences and industry. Reviewing sponsor provided data, results, methods and standard operating procedures. Evaluating drugs for compliance to Federal Regulations and writing product quality regulatory reviews for chemistry and manufacturing control submissions for INDs, BLA and BLA supplements for Monoclonal antibodies, Bispecific antibodies, Antibody cocktails, Antibody drug conjugates, Antibody-cytokine fusion proteins, Antibody-bacterial toxin fusion proteins, and Radioimmunoconjugates.

Education

Antonina holds a PhD in Human Genetics (University of Maryland, Baltimore, MD) and a bachelor’s degree in biotechnology (Sofia University, Sofia, Bulgaria). 

We are always available for a conversation.

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