Biopharma Process Experts

• Fractional or Full time Leadership for your internal team

Do you have a large project that is overwhelming your management resources?

Is the technical review and approval process for critical documents proving to be a bottleneck? We can help.

Are you a small company in early-stage clinical trials preparing to set up phase appropriate policy and procedures for late stage? We can help.

Have you lost a key manager? We can provide interim management and help with the transition.

We can provide program/project management utilizing appropriate waterfall, agile or Kanban methodology.

• Technical advice and support for your internal team

We have deep industry experience and track record of solving difficult problems.

We analyze, we collaborate, we design solutions

We develop phase appropriate policies, procedures and protocols.

We are skilled in risk management tools, 6 sigma and lean techniques.

We use Gemba walks in our CGMP Audits

We bring process insights, knowledge of industry best practices and can recommend improvements adapted to your needs.

• Team Building

We have expertise in creating high performance teams, integrating external and internal resources. We have deep industry experience and enjoy mentoring the next generation of leaders. We bring project and program management expertise.

• Bring in additional resources, to supplement your team

• Work in partnership with your contract staffing provider to build a team

• Flexible Work Arrangements

We offer fractional (part-time) or full-time resources for cost effective solutions based on your needs.

We are flexible and can work onsite, remotely or in hybrid formats.

We are open to travel to third party sites as needed.