Excellent Execution
Our actionable advice and disciplined approach has delivered successful projects for our clients including:
- Design and implementation of a GMP quality management system for a biotechnology sponsor in Exton, PA
- Design and implementation of a GCP quality management system for a brand new Phase 1 clinical trial unit in Baltimore, MD
- Advisory services for an analytic reagent manufacturer in San Carlos, CA; resulting in successful ISO 13485 registration
Experience
Our Director and Senior Consultant is a certified and experienced quality and management professional with over 10 years experience in biotechnology quality assurance and over 13 years in project management experience involving complex technical projects.
Our project partners are drawn from degreed and certified professionals in the biopharmaceutical program management, project management and quality management disciplines and have a minimum of 5 years experience in their respective specialties.
Flexibility
Our project associates are flexible.
We can
- Take the lead and manage project resources
- Integrate as team quality representatives
- Work as temporary team members
- Manage ad-hoc projects
- Perform infrequent activities such as auditing, validation, and crisis management
Management Commitment
"When I run a project, I look at it from all angles and focus on delivering what is required to ensure value to the stakeholders. I have a technical background so I can ask the right questions from both business users and technical staff to ensure that we know the requirements and can build a solution that meets your needs." – Stephanie Skipper