Pavani G.

Pharmacokineticist | Toxicologist | Regulatory Science Expert Freelancer | Independent Scientific Consultant Dr. Pavani Gonnabathula is an accomplished pharmacologist, toxicologist, and regulatory science expert with over 8 years of experience supporting the pharmaceutical, biotech, cosmetics, medical device, and environmental health industries. Her multidisciplinary expertise bridges pharmacokinetics, toxicology, and regulatory science, ensuring safe, compliant, and effective product development across a range of sectors. With a Ph.D. in Environmental Toxicology and extensive postdoctoral research at the U.S. Food and Drug Administration (FDA) and CDC/ATSDR, Dr. Gonnabathula has led numerous PBPK modeling projects to optimize dosing strategies for pediatric and perinatal populations, and to evaluate the health risks of environmental chemicals, with a strong emphasis on vulnerable populations, especially children. She also brings specialized knowledge in medical device safety, conducting risk assessment, risk characterization, and biocompatibility evaluations in alignment with ISO 10993 and FDA requirements. Her expertise extends to cosmetic ingredient toxicology, supporting regulatory safety dossiers using computational modeling, NAMs, and internationally recognized toxicological frameworks (EU and U.S.). Technically fluent in platforms such as Simcyp, PK-Sim, Berkeley Madonna, GastroPlus, MonolixSuite, NONMEM, and R, she applies cutting-edge tools to drive data-informed modeling, exposure predictions, and regulatory evaluations. With a Graduate Certificate in Regulatory Science, she is adept at navigating FDA, EPA, ISO, and ICH regulations and brings hands-on experience in clinical trial design, GMP, GLP, and GCP practices. Areas of Expertise: PBPK/PBTK modeling and dose optimization Toxicological risk assessment for cosmetics and medical devices Biocompatibility testing and ISO 10993 compliance for medical devices Exposure assessment and safety evaluation of environmental and consumer chemicals Drug-drug interaction modeling, pediatric pharmacology, and ADME/DMPK studies Scientific writing, regulatory documentation, and peer-reviewed research Why Work With Dr. Gonnabathula: Research experience with USFDA and CDC on national safety and public health initiatives Deep understanding of cross-industry regulatory frameworks and predictive modeling tools Proven publication record and recognition in pharmacology, toxicology, and computational modeling Custom-tailored support for regulatory submissions, product safety reviews, and model-informed strategies Open to freelance and consulting engagements in pharmacokinetics, toxicokinetics, PBPK, PK/PD modeling, medical device risk assessment, cosmetic ingredient safety, regulatory strategy, and toxicology support.