Fast-track new product development project for small-molecule injectable. Delivered ambitious method validation and stability programme. Dossier preparation and review, response to authority questions.
Product quality issue. Systematic root cause investigation and data analysis carried out. Formulation change proposed and implemented. Presentation to senior management and regulatory body to get buy-in for approach.
Geographic expansion of legacy product. Dossier gap analysis and updates. Management of analytical CRO to carry out identification of new impurities and method update.
Process development for autologous cell culture. Identification of critical process parameters. Dossier update for clinical trial application.
Formulation development for oral dissolvable film and product transfer to CMO for manufacturing of clinical trial material. Project management. Dossier generation.
Drug substance: small molecules, peptides, biologics, cells
Drug product: injectables (solutions, emulsions, lyophilisates), solid dosage forms, oral dissolvable films