PTS Pharmaceutical Consulting
Over 30 years of experience in the pharmaceutical and related industries
PTS Consulting Global Services has been actively involved in pharmaceutical consulting, including product development and support activities including but not limited to, preclinical, clinical, bioequivalence studies, chemistry & manufacturing controls and filing/approval of drug applications. PTS Pharmaceutical Consulting Services is also involved in FDA review management of drug and biologic applications and approval/launch activities for numerous products some of which required circumventing of patents and exclusivities.
Filing and Managing all of the Processes for FDA Drug Applications
FDA and Global Regulatory Compliance and Submission
Complete Facilities Design from inception to full FDA qualification