At the initial planning stage, we work with you to capture your needs and expectations. Together we form the project team, define the scope of work, and plan every aspect of the project, including resources, quality, production, and communications.
High-level outputs
- Develop project schedule
- Create resource, staffing, and training plans
- Determine facilities plan and timing of site visits
- Design quality plans and agreements and master validation plan
- Assess risk and create a mitigation plan
- Determine regulatory requirements
- Prepare supplier qualification plan, supply agreement, and inventory plan
- Design equipment transfer and development plan
- Develop capacity plan and production forecasts
- Prepare production ramp up plan
- Complete the post-launch continuous improvement plan
Results
Through a facilitated, multi-day planning session, our collective team will accelerate the planning with an in-person kick-off meeting. We develop requirement documents for review and approval by the Tech Transfer team before moving on to the next phase, and achieve strong alignment in a short amount of time.
Tools
We use a detailed tech transfer process—with checklists and forms, following established standard operating procedures and ISO requirements—to consider and plan for every requirement for the tech transfer. We work closely with you to discuss trade-offs, align on key decisions, and find the best solutions for your goals.
