Nadia Cristiano

Regulatory Toxicologist

Email: moc.k1500864065isnir1500864065tni@o1500864065naits1500864065ircn1500864065
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Nadia Cristiano is a Regulatory Toxicologist at Intrinsik Corp., whose primary focus is on assisting with nonclinical program design, implementation, and monitoring of nonclinical studies in support of regulatory applications. She has over 14 years of hands-on experience in nonclinical safety program development and has extensive project management experience. Nadia is responsible for ensuring the overall quality of nonclinical studies through pre-placement and in-process study audits and monitoring, including performing routine quality checks to ensure critical activities are performed in conformance with the requirements specified in applicable GLP regulations, protocol requirements, and SOPs. She is proficient in GLP-driven facility inspections to ensure CRO compliance with all aspects of federal regulations, including built-in quality and control systems and appropriate incorporation of those systems in the execution of nonclinical studies. Nadia also authors nonclinical sections of regulatory submissions, including pre-IND/pre-CTA, IND/CTA, and NDAs/NDSs, and investigator brochures for a broad range of therapeutics. Having previously worked in both pharma/biotech and CRO environments, Nadia has gained valuable knowledge of effective strategies for early drug development.

Experience Highlights

  • Project management of nonclinical research activities conducted by external service providers.
  • Interacting with clients, CROs, and subcontractors to oversee quality, timelines, and budgets for nonclinical studies.
  • On-site monitoring of in-life activities at the CROs to ensure scientific integrity and compliance with GLPs.
  • Qualification of CROs through conduct of GLP-driven facility inspections.
  • Selection of CROs to execute drug safety studies.
  • Writing and/or reviewing of scientific study plans, reports and proposals.
  • Analyzing and interpreting toxicological data.
  • Providing scientific and regulatory input in solving of issues.
  • Authoring nonclinical sections of regulatory submissions.

Education and Professional Qualifications

  • B.Sc. (Specialization), Cell and Molecular Biology, Concordia University

 

Join Our Team

Intrinsik Corp., is a dynamic science-based consulting firm.  We are eagerly interested in professionals to add to our accredited staff base.  Intrinsik is strongly committed to our employees by ensuring mentoring, training and advancement for those with a drive to succeed.  Our areas of expertise include and are not limited to toxicology, human health and environmental risk assessment, biology, multi-media exposure modeling, environmental science, and risk management.

Diversity is not only part of our company’s culture, it is a core business strategy.  We are building a workforce that is representative of our society, and our programs and policies are designed to foster diversity and inclusion.

AODA Declaration
Our goal is to create an environment that is inclusive to all members of the community.  Intrinsik Corp., focuses on identifying, removing, and preventing barriers for persons with disabilities, and our policy complies with the Accessibility for Ontarians with Disabilities Act, 2005 (AODA).

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

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