Managing the transition from a state of crisis to one of control rests on a capable, competent team.

In today’s fast paced environment where the strongest leaders are scattered across multiple important projects, anticipating and managing crises has become more difficult. Challenges may include an unexpected product safety or quality concern, compliance, organizational, or facilities/equipment issue.

We offer perspective, experience, leadership and support to complement your team in averting crisis, developing options and supporting execution in challenging times.

More than ever before, the Pharma industry faces the growing need to accomplish more with less. Your need may be to manage more clinical studies, submit more dossiers, manufacture and test more batches, or revise more product labels, more quickly, with less staff. We have the depth of experience to understand your specific objectives and help design and deploy the correct organizational, operational, and technological solutions.

Short term gaps in capacity and/or capability can hamstring an organization’s ability to work strategically and to meet operational requirements.

We listen, build relationships, and provide trusted experience to help you manage these gaps across Quality, Compliance, Manufacturing, Pharmacovigilance, Labeling, Program/Project Management, etc. We help prioritize benefits and risk, working efficiently and effectively to meet regulatory commitments and other imperatives (e.g. FDA Consent Decree, Warning Letter, 483, CAPA, etc.).

We take pride in structuring coordinated transition plans to help develop your staff and ensure sustainable continuous improvement. Please reference the sample Focused Support CAPA deck.

Industry mergers, global marketing, and the need to differentiate products often mean product lines that, over time, have become far too broad. This negatively impacts both profitability and compliance.

Few organizations capture the advantages of understanding the relative cost/benefit and allocating the correct level of resources through lifecycle management.

We can help you refocus your organization on priority products by establishing criteria to screen your products/sku’s and implementing a product rationalization and out-licensing program.

We value lengthy partnerships with our clients based on understanding their needs and accomplishing transformational, sustainable gains in performance. While we recognize that our role is transitional, we strive for our impact to be long-lasting.

We are relentless in defining, communicating, and achieving a shared vision through teamwork.

Clients say our unique perspective with an average of 15 years of industry experience across major functional groups sets us apart. From R&D and Clinical Development to Regulatory, Quality, Manufacturing, and Sales & Marketing, we understand how the pieces fit together and help anticipate both opportunities and obstacles.

We set high standards for both designing and helping to implement change.

Successful projects evolve from Initiation and Discovery through Design and Implementation. Leaders and staff are engaged in accomplishing clear goals and objectives across process, people, and technology. Success rests on a shared vision, structured teams, delegation, empowerment, regular communications, and accountability.

Established concepts and tools support successful project delivery (e.g., lean enterprise, organizational development, change management, web enablement, Six Sigma, process mapping, FMEA, 80/20, root cause analysis, ABC, statistical process control).