Inovaphar.com provides all services related to the product Development and the Regulatory in the area of Lifes Sciences and more particularly in Pharmaceutical industry
- Project Management
- Pharmaceutical Development
- IMPDs/INDs
- Module 3 CTD
- Module 2.3 (Quality Overall Summary)
- Expert statements (1.4.1 & 1.7.1)
- Variations
- Answers to Questions
- Support for post market OOS management
- Briefing book
- Regulatory review of Product Quality Review (PQR)
- Support for Scientific Advice
- Support forType C meeting
- Support for Break out session
- Support for Pre-submission meeting
- Project management as member of the prohect team
- Training in CMC and Regulatory CMC
- Due diligences for project or product acquisition
- Quality and Regulatory audits
We adapt ourselves to your organization and we can work directly in your electronic documentation management system (EDMS)
We also can accompany you in your communication with the different Authorities worldwide.