PTS Consulting Global Services key fields of expertise range from preparation of drug, food and/or cosmetic facilities from inception to full FDA qualification and filing.
Managing the processes for FDA drug applications especially Abbreviated New Drug Applications (ANDAs), INDs (Investigational new drug) and 505(b)(2) NDA and BLA applications.
PTS Global Services has over 30 years of experience in pharmaceutical consulting in the worldwide generic pharmaceutical market, we provide unparalleled experience across the value chain with extensive knowledge of drug development processes acquired through hands-on and didactic experience in all aspects of drug product development and problem solving, drug registration regulation and R&D activities.
Pharmaceutical Sales & Marketing
PTS Consulting has extensive experience in sales and marketing for several multi-national pharmaceutical operations in North America, Europe and Asia
US FDA Regulatory Qualification & Compliance
Full FDA qualification and filing and managing the processes for FDA drug applications especially Abbreviated New Drug Applications (ANDAs), INDs (Investigational new drug) and 505(b)(2) NDA and BLA applications.
Thorough knowledge of pharmaceutical regulations in USA, Canada and European Union, Asia and other countries and is serving as US agent and advisor for numerous pharmaceutical companies firms located and/or operating in these regions.
understands the critical importance of complete and accurate regulatory submissions and can collaborate on submission planning and preparation to ensure consistency, scientific accuracy, completeness, and regulatory compliance of all processes and documents and processes.
Pharmaceutical Product Development Expertise/Guidance
Highly entrepreneurial product development team with proven track record.
Can advise on the most efficient way to design and conduct development programs to maximize success during all phases, from pre-clinical to post-approval, expediting products through clinical trials and into the market. He also helps clients develop strategies, examine alternatives, and identify tactics to deal with ever-changing regulatory pathway for 510(k) Medical Devices, ANDA, 505(b)(2) NDA, NDA, BLA and other FDA and EU applications.
Highly Compliant Pharmaceutical Manufacturing
Operational excellence in quality and compliance, with in-house manufacturing capability.
PTS Consulting Global Services has been involved in design, establishment, qualification and management of various pharmaceutical manufacturing business operations as CEO and Owner and has managed numerous drug applications with the US FDA.
PST has a relationship with Dr. Pawan Seth, one of the pharmacuetical industry's most prolific innovators.