With expertise in "hard-to-make" generics, we can support you with any pharmaceutical dosage form development
Working in close collaboration
- We offer our expertise in the assessment and selection of new project
- We analyze your needs and objectives to propose tailor-made development strategies
- You will receive regular and accurate progress reports on the project status
- You will always be consulted for strategic project decisions
- You can benefit of advices from independant experts of our consortium throughout the project
- We support you in the resolution of technical issues experienced during the project
- We stand up for your interests when dealing with subcontractors
Project management activities include
- Establishement of development plan, budget and timelines.
- Establishment of QTPP and RFQ.
- Assessment of offer and recommandation of performance.
- Screening of CMOs and technical visits.
- Establishment of development protocols (ICH Q8, Q9, Q10 and Q11).
- Rolling out of activities as per ICH Q1, Q2, Q3 and Q6.
- Implementation of DP manufacturing process, scale up and validation.
- Technology transferts and manufacturing troubleshooting.
- Follow up of action with CDMO