Case Studies

Our client needed to refine their late-stage regulatory strategy on the path to approval. Discover how Halloran’s regulatory strategy and program management approach enabled success.

Halloran’s inspection readiness methodology paired with practical recommendations moved our client one step closer to inspection success.

When we were engaged, our client needed to stabilize operations, establish processes, align roles and responsibilities, and enable employees to focus on their workstreams. Learn Halloran’s step-by-step process.

Discover how Halloran addressed our client’s organizational problems in a multi-phased approach, resulting in successfully organizing their 20+ programs.

After evaluating gaps in our client’s processes, Halloran implemented best practices and enhanced communication to incite marketing application readiness.

Halloran addressed our client’s infrastructure gaps to move from a fragmented organization to an integrated unit to prepare for a successful first NDA submission.

When approached, Halloran developed an integrated development plan for the client, showing a fast pathway to Proof of Concept as a competitive advantage.

When Halloran stepped in as our client’s Development Program Manager, the company successfully filed their Biologics License Application.

When hired, Halloran provided a remediation strategy and a tactical plan to our client to prepare for regulatory submission to remain compliant with the EU MDR.