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
    • Development of master batch records and SOPs

Quality

    • FDA and regulatory agency GXP compliance
    • Preapproval inspection (PAI) readiness
    • Systems implementation and improvements
    • 483 observations and warning letter remediations
    • Validation documentation

Marketing and Sales

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

 

Clinical Operations and Development

    • Clinical program and SOP development
    • Data and records management
    • Clinical trial management
    • Clinical study reports (CSRs), investigator brochures (IBs), and study publications

Regulatory

    • Submission writing and data verification
    • Labeling and print materials
    • Submissions project management
    • INDs, NDAs, BLAs, 510(k)s, and PMAs

Supply Chain

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