Expert in scientific writing and regulatory advice – CMC regulatory submissions and supporting documentation such as stability or validation reports and responses to Regulatory requests/questions.
Visible particle investigations/strategy
Analytical method development
Control strategy design
Product specification development
Stability program design
Analytical Method Validation
Scientific Writing such as BLAs and INDs
Pre-inspection Audits
Training in GMP, Analytical methods, characterization and control strategy
Justification of specifications
Comparability Strategy
Biosimilars
ADCs, vaccines and proteinaceous products
