Our expert QW consultants have the skills needed to effectively guide you through product development for generic molecules, from RLD procurement to successful marketing authorisation. We use our flexible and creative approach, combined with our deep understanding of the global regulatory environment, to help our clients navigate their development seamlessly, maximising the chance of success for medicines. Project management services includes Product development strategy based on marketing region requirement.

• Sourcing of RLD
• Sourcing of all material required for generic formulations
• Identify right contract development and manufacturing facility 
• Lead the project with development scientist 
• Keep tract on each stage of the project and report timely to the customer 
• Formulation development support 
• Process optimisation support 
• Tech transfer to a GMP approved facility 
• Validation batch manufacturing 

• Identifying right clinical centre for BE study
• BE study protocol review and approval 
• Procurement of RLDs 
• Database management to hand over to regulatory colleagues for dossier compilation.