focus areasdeep knowledge. mature experience. this is where we put it to use.

Whether it’s something we know inside out or something we have yet to see, our thinking is always fresh, our resources are always ready. Examples of projects include:



 

Manufacturing

    • Facility commissioning, modifications and licensure
    • New product introductions, technical transfers, product development
    • Efficiencies and streamlining

Quality

    • Regulatory agency actions and remediations
    • Systems implementation and improvements
    • Critical corrective actions
    • Validation documentation

Marketing and Sales

    • Product launches
    • Reimbursement and patient assistance programs
    • Promotional materials and user documentation
    • Sales training

 

Medical Affairs

    • Clinical program and SOP development
    • Data and records management
    • Clinical trial planning and management

Regulatory

    • Submission writing and data verification
    • Labeling and print materials
    • Submissions project management

Supply Chain

    • Contract manufacturer and supplier selection, qualification and management
    • Inventory and supply crisis management
    • Complex and international supply chains and distribution channels