PPD® Laboratories’ bioanalytical lab is actively involved in the development of generic pharmaceuticals. We have worked with more than 65 generic pharmaceutical companies from all over the world.
The development of generic drugs has unique characteristics that require an experienced laboratory to ensure successful and timely project completion. Our bioanalytical lab takes a proactive approach to method development for generic products by beginning early in the development lifecycle. We support analysis for formulation development in addition to supporting pilot and pivotal studies.
The experience of the PPD Laboratories bioanalytical lab with generic products is extensive. We have supported more than 1,600 generic drug development studies and have analyzed over two million samples. We have conducted numerous first-to-file projects and delivered results for many thousands of samples within a short period of time.
The unique regulatory environment for generic pharmaceuticals also requires an experienced development partner. The Abbreviated New Drug Application (ANDA) process has strict guidelines that require attention to detail and rapid turnaround to support Paragraph IV first-to-file submissions. We have successfully completed more than 70 on-site U.S. Federal Drug Administration (FDA) inspections for ANDA programs and our data has supported regulatory approvals through Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), Brazil’s National Health Surveillance Agency (ANVISA), Health Canada and the FDA.
Explore our experience: