Our key personnel bring hands-on experience in all phases of biotechnology management starting with strategic planning up to site validation IQ/OQ/PQ. It is therefore, that we at Vanir Bio understand the crucial impact of project managment and its key importance to a biotechnology project.

Project managment in our view would include aspects such as:

• Understand and develop site options and master plan issues
• Develop operations criteria, manufacturing, and throughput goals
• Ensure alignment with functional unit and regulatory issues i.e. FDA, EMEA
• Identify the appropriate technology to meet strategies and objectives
• Ensure appropriate review and approval(s) which occurs before moving on
• Factored budgets, cash flow, and timeline forecasts
• Establish site after selection criteria is implemented
• Develop, or oversee the development of a Validation Master Plan
• Select special service providers as required
• Develop, or oversee the development of a concise program (capacity projections, type & size of spaces, quantity, people/process flows, utilities, preliminary equipment lists)
• Develop Request for Proposals (RFP’s), which integrate all project objectives and requirements, into a seamless package in order to select the premiere consultants and contractors
• Oversee or assist with the oversight of the special services and/or contractors performing the remaining phases of the project ensuring all program requirements are met and all options are explored.
• Lead or assist with Factory Acceptance Testing e.g. cGMP
• Project fundamentals and progress monitoring and reporting including: budget; schedule; change control process; quality control
• Assist in the development and execution oversight of all installation, operation, and process qualification documents and activities