Worked with a US start-up to develop a practical proposal for meeting governance requirements against applicable codes.
What
The remit of this consultancy was to develop a pragmatic process for review of materials for a small clinical stage start-up business, wishing to establish their European base. The consultant they engaged was UK-based.
The Challenge
With their sole candidate in the clinical stage and no in-house signatory capability, the client wanted to ensure a cost-effective method of ensuring all materials to be developed for the launch phase were compliant with all applicable codes and met other reporting requirements. I worked with their consultant to develop a solution
Activities.
The starting point was establishing the trajectory of pre-launch activities, timelines for commencement of promotional activities and planned organisational structure and capabilities within the team, to establish the most appropriate solution for this business.
Based on this, applicable codes within those countries, and then reviewing the most suitable approach based on these, to ensure that all materials or activities met the most stringent guidelines.
Solution
A number of solutions were proposed; using an external contractor on a retainer, a full time consultant or a third party vendor these proposals were accompanied by risks and benefits and some simple heuristics which could be applied to determine where activities might fall.