Let me support you in the following services:

Get in touch, I’d love to help

Clinical Trial Application Support:

Application planning and strategy, package preparation and submission, coordination of RFI’s, tracking and life-cycle management.

Clinical Trial Supporting Data Package Review:

Review of your trial strategy; draft package review to identify potential data gaps/reg hurdles; therapeutic area considerations; design and IP considerations; country and site nuances and timelines.
Sponsor proposal, RFI and BDM strategy, preparation and delivery:
Proposal review/input, BDM or preferred provider presentation preparation and attendance for delivery of bespoke Regulatory Considerations.

Experienced sponsor disappointment that support delivered drops off post study award? Let me help in:

Seamless transfer from pre-award to post-award. I can support you in ensuring an effective link between the sales and operational teams to ensure the assigned reg opps teams are provided with all relevant pre-award documents, discussions, client hot-points, budgets etc to avoid any perceived drop off in client support and hit the ground running in operations at project start.
Client relationship development:
Communication strategies, use of soft skills, client hot-spots, document requirements & responsibilities, project timelines, tracking, lessons learnt etc.
Consider having me as an assigned regulatory relationship lead covering a suite of sponsor studies. This can provide bespoke regulatory management across the board, issue escalation and one stop sponsor contact for all regulatory updates.
Struggling for time for on-boarding new Regulatory Staff? Let me help in:

Regulatory staff on-boarding activities, regulatory training, implementation of company ethos, SOPs etc

Preparation for Regulatory Agency Meetings:

Ad hoc Regulatory questions, review and support.

Being available to provide expert regulatory support to teams as and when required.