Biologics

PDG is your Biologics Consultant 

In today's marketplace, the development and manufacture of biologics is competitive and highly regulated. PDG's, experience in preparation and review of Biologic License Applications to CBER and CDER could mean the difference in being competitive with a successful launch or costly delays.  At PDG, we can tailor product-specific strategies to maximize both safety and profitability throughout the lifecyclye of your product.

• Biological License Applications (BLAs)
• Biosimilars
• Facility and Pre-Approval Inspection
• GLP/GMP audit preparation and response
• Amendments and Supplements to your BLAs
• Post marketing safety surveilance
• Quarterly and Annual Reports
• Regulatory Consulting