The International Regulatory Affairs Network
Drug Development - Regulatory Strategy And Management For Drug Development
- Provide regulatory advice in the early phases of development projects
- Define the product concept
- Interpret regulations and guidelines
- Develop strategies for technical aspects of drug development (quality, preclinical and clinical)
- Design and manage drug development programmes
- Determine market access requirements and develop a strategy in the early phases
- Identify and manage external resources/experts
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