Larger pharma company regulatory affairs departments are constantly being asked to do more with no increase in resources. Smaller companies and foreign companies often do not have any or enough US based staff or staff with the appropriate expertise to meet their business goals. Thus the use of consultants to provide assistance is a significant and growing trend in both the pharmaceutical and medical device industries.
But how does one go about choosing a consultant group? Use a big CRO-type organization? Contact a single proprietor? Are there alternatives to consider in terms of therapeutic area, geography, on-site or remote work, other potential add--on services that are offered, etc.? This session will present the perspectives and learnings of a senior regulatory affairs executive with decades of successful experience in choosing and utilizing regulatory consultants for both tactical and strategic activities. Attendees will learn the right questions to ask and all the points to consider in consideration of bringing on a consultant.
The second speaker will present many of the same processes and perspectives from the side of the consultancy. What information should you provide to allow a consultant to appropriately scope out, determine timelines and resources, and price a project? How should one compare proposals from different consultants? What should you verify with a consultant before signing the contract? An experienced consultancy executive will provide these insights and advise participants on what is needed to make the relationship work smoothly so that your objectives are fully realized.
Use of regulatory affairs consultants in the device/pharma industry is projected to continue to increase by 10% or more annually. Intermediate and senior level attendees will be able to apply the information shared during the presentations and Q&A session in their normal work activities as they consider adding consultants to complete business objectives.