Experience

SYNAVIA

• Czechia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Biopharmaceutics and Regulatory Consultant

  • Apr 2020 - Present

  ~ CMC support: ASMFs, CEPs, impurities, assessments, QOS~ CTA support: IMPDs~ Formulation development support, dissolution data evaluation, dissolution method development (QC/discriminative/biorelevant)~ Procedural support, Module 2 scientific writing, responses to deficiency letters~ BCS-based biowaivers~ Module 3 expertise



Freelance

• Egypt
• Human Resources
• 1 - 100 Employee

• Biopharmaceutics and Regulatory Independent Consultant

  • Aug 2017 - Present

  Independent consultant with nearly 15 years’ experience in generic pharmaceutical development and regulatory sciences. Focused on biowaiver strategies (with special focus on BCS-based biowaivers), Module 3 expertise, dissolution data analysis and in vitro-in vivo correlations. Solid Module 3 background directly derives from the working experience in generic pharma analytical development. Further fields of interest include medical writing, including Module 2 overviews, impurities assessment, and justifications for RA. Strong impact on updates in the EU regulatory environment, draft ICH guidelines, reflection papers, etc.



PharmInvent

• Czechia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Scientific and Regulatory Specialist

  • Sep 2015 - Aug 2017

  Regulatory sciencesScientific advice supportMedical writing (COs, NCOs, BCS-based biowaivers, impurities toxicological assessment, etc.) Bioanalytical monitoring (as part of CT monitoring)



Zentiva

• Czechia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• R&D Documentation Manager

  • 2008 - 2015

  Module 3 supervisionStrength biowaiversResponses to deficiency letters of registration authoritiesRegulatory supportPortfolio careTransfer of analytical methods

• R&D Senior Analytical Specialist

  • 2004 - 2008

  Formulation development supportAnalytical methods development, validations, and transferInterdisciplinary interpretation of development data, assessment of biorelevanceFinished product specificationModule 3.2.P compilationImpurities assessmentDissolution testing as an in vitro tool