In our capacity as a pharmacokinetic consultant to both ANDA and NDA sponsors, PDG has participated in all phases of the regulatory and development processes.
We routinely select, qualify and audit contract laboratories and CRO facilities. PDG also compiles, reviews and edits pharmacokinetic study protocols. Depending on the details of the program, PDG can design the study to generate protocol planning information for your pivotal clinical studies to optimize the success of meeting your primary and secondary endpoints. We have also been asked on multiple occasions to resolve validity issues (occurring prior to PDG consultation) identified in FDA audits, and have done so with minimal additional study efforts required. FDA concerns with the integrity of bioequivalence data can be devastating and include scenarios such as studies being repeated or drugs being withdrawn from the market. We know firsthand, FDA precedents relating to new studies and reanalysis options. As such, PDG is uniquely positioned to audit and make recommendations with regard to meeting your pharmacokinetic study needs. Contact us for help.