Project Management

We can provide technical project managers who both understand the activities that need to go into the project and ensure those activities are completed in the right sequence and on time. We apply well-proven project management tools and best practices (meeting agendas and minutes, Gantt charting and project plans, dashboard updates, activity tracking, risk analysis and decision making software). Our project managers can provide detailed or high level status reports that help identify bottlenecks or critical tasks, helping you efficiently focus on the right efforts to a successful conclusion.

Strategic Planning

Technology assessment

Intellectual property

  • Working with patent attorneys to assess the intellectual property space
  • Assessing patent approach

Business development

    • Assessment of various business models
      • Development strategy
      • Manufacturing strategy, including selection and management of contract manufacturers and/or testing labs
      • Analysis of making versus buying

Identifying benefits/risks of different approaches

Product development – from start to finish

  • Process
    • Manufacturing strategy
    • Feasibility assessment
    • Long term plan
    • Process/product integration
  • Analytics
  • Dosage form

Quality / Compliance

  • Quality-technology approach
  • Implementing a quality system

Technology Transfer and Validation

  • Development of strategy and approach to streamline scale-up efforts
  • Master planning, scheduling and tracking of validation efforts
  • Project team management
  • Composing and reviewing scale-up documents, including:
    • Pilot scale characterization protocols and reports
    • Small scale model protocols and reports
    • SOPs, batch records, and related GMP documents
    • Process flowcharts
    • Commissioning protocols
    • Validation Master Plan, protocols, and reports
  • Development of dimensionless correlations and scaling factors
  • Troubleshooting differences in process performance at different scales
  • Risk assessments of process methods, process additives, and leachables/extractables
  • Gap analysis
  • CMC section writing and review for global regulatory submissions
  • Specification development and parameter classification
  • Technical investigation of deviations and out-of-specification results
  • Hands-on assistance during engineering runs, commissioning, validation, and other process implementation activities (person in plant)

Facility Design and Construction

  • Process design and modeling software
  • Oversight
  • Timeline management
  • Process and related equipment validation, including utilities, computer systems and other automated systems
  • Risk assessments and gap analysis

Contract Supplier Management

  • Identification of appropriate contract manufacturer, supplier, or testing lab
  • Comprehensive and strategic coordination of all activities at contract facility
  • Coordinating details of the hand-off between your company and contractor
  • Document writing, review and approval
  • Hands-on assistance during tech transfer and implementation activities at contract facility

Clinical Trial Materials Management

  • Identification of appropriate service providers for packaging and labeling
  • Comprehensive and strategic coordination of all materials for clinical trials
  • Coordinating the logistics for receipt and delivery of materials
  • Document writing, review and approval

Quality Systems Tracking

Coming soon.