Project Planning and Management

BPS understands that biologics projects have their own unique set of challenges starting with a Basis of Design through eventual licensure. We have provided both long term and short term solutions to numerous projects including the following general scopes:

  • Clinical development stage: Management of expectations and deliverables between client, CMOs, external testing labs and licensing authorities.
  • Design development stage:  Coordination between client, engineer(s), equipment fabricators and other parties responsible for CQV activities.
  • Equipment fabrication stage: Management and alingment of fabrication timetable with FAT, installation, SAT and CQV activities
  • CQV stage: Management of timetable and detailed coordination of daily activities between installers, operations/start-up team, utitities leads, CQV service providors, testing labs and consumables providers.
  • Post IOQ stage: Coordination and management of activities for water runs, start-up batches and process validation