PTS 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.
We have been involved in establishing and managing full-fledged, FDA qualified manufacturing operations from the ground up and obtained FDA clearance for those facilities.
Our manufacturing and analytical services are provided from early clinical research & development all the way to commercial production. Our streamlined processes facilitate timely production of high quality pharmaceutical or cosmetic products at the lowest possible cost.
PTS works with a diverse group of products and clients. We have expertise in various tablet, capsule, liquid, ointmnet and cream manufacturing processes. Our US, European Union and Asian clients range in sizes from the largest pharmaceutical companies to virtual companies.
We can provide warehouse functions for receiving, shipping, quarantine, climate control, data management; order processing and other outsource logistics services. PTS has the capability for the distribution of prescription pharmaceutical drug products throught the U.S.
PTS Global Services offers our manufacturing partners TurnKey expertise:
- Initial product identification and selection
- Market, financial, regulatory, and legal analysis and due diligence for new product opportunities
- cGMP-compliance oversight and gap analysis of manufacturing sites
- ANDA preparation, submission, prosecution and interface with FDA
- Regulatory services and support
- Patent review/analysis
- Paragraph IV litigation strategy and management
- Sales, marketing, warehousing, and distribution