Drug Safety Strategy Consultancy
Innovative approaches to optimise your drug safety business
Drug Safety Strategy Consultancy
Innovative approaches to optimise your drug safety business
Innovative approaches to optimise your drug safety business
Innovative approaches to optimise your drug safety business
Mitigating patient risk
Managing emerging safety issues
Regulatory agency interactions
Business development
M&A
Organizational design and integration
Technology assessment and integration
Supporting pharmaceutical and biotechnology companies of all sizes in optimising the safe and effective use of their medicines and devices throughout development, regulatory approval, launch and the marketed setting. Areas of expertise include medical safety, proactive signal management, including issue management, pragmatic risk management approaches, harnessing real world data in evidence generation. Significant experience in negotiating with all major global regulatory agencies (FDA,EMA, MHRA, PMDA, Health Canada), business partner relations, as well as evaluating business development opportunities.
Optimising Drug Safety department structure, role accountabilities and responsibilities within the broader company matrix to enhance decision-making speed and execution efficiency. Experience in setting up new Drug Safety departments through expanding and restructuring existing safety teams during company globalisation, or as a result of M&A. Refining business processes to ensure efficiency while meeting global regulatory agency expectations, including through organisational integrations and beyond.
Evaluation of the internal and external technology landscape, identify and implement solutions to increase efficiency, improve quality, and ensure compliance, including effective change management and communication strategies.
Supporting VCs and management consultancies in assessing software and other digital business development opportunities for clients.
Advising software developers in enhancing their Safety and PV offerings to become more competitive in meeting their clients’ business needs.
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