serving the pharmaceutical & related industries

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.

EXPERTISE

PTS Consulting Expertise

PTS Consulting has over 30 years of experience in pharmaceutical related industries, working with clients and governing bodies to prevent or resolve U.S. FDA compliance issues. We have extensive knowledge in pharmaceutical regulations and serve as the US agent and advisor for numerous pharmaceutical firms in the US, Canada, the European Union and Asia.

more

PARTNERSHIPS

PTS Consulting Global Services Pharmaceutical Research

We're involved in the forefront of product development, analytical testing, manufacturing and clinical & pharmacokinetic testing of high quality off-patent pharmaceuticals. PTS consults on investigational research in a clinical trial using the patient's own stem cells to assess the efficacy and safety for patients with advanced Critical Limb Ischemia.

more

pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

More...

Application

Pharmaceutcal Applications

Filing and Managing all of the Processes for FDA Drug Applications

More...

Compliance

Pharmaceutical FDA Compliance

FDA and Global Regulatory Compliance and Submission

More...

Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

More...