Sourcing Active Pharmaceutical & Other Ingredients

PTS Pharmaceutical Consulting Global Services provides expert services that accurately identify global manufacturing resources and evaluate the best technologies available for each client’s Active Pharmaceutical Ingredients and Fine Chemicals and Intermediates sourcing requirements. With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging.

Working with our partner companies worldwide, we ensure critical elements of an existing product are successfully transferred into the new source. The capabilities of the network contained in our environment allow us to successfully place most outsourcing inquiries and ensure strict compliance.

ACTIVE PHARMACEUTICAL INGREDIENTS

PTS Pharmaceutical Consulting provides an extensive line of Active Pharmaceutical Ingredients. We have numerous products available across our partner Network. Our sourcing abilities are greatly enhanced by an in-depth knowledge of manufacturing plants worldwide and a sales team characterized by experience, reliability and responsiveness. With our extensive experience, we are able to provide a thorough understanding of the regulatory requirements needed to meet your sourcing objectives.

FINE CHEMICAL AND INTERMEDIATES

PTS Global Services provides sourcing of custom synthesis and manufacturing for the pharmaceutical industry. Our focus is to deliver custom intermediates and process development strategies from laboratory scale to pilot plant and full production. The custom manufacturers partnered with us are leading CGMP/ISO companies. Most of these partners are regularly inspected by the FDA, and all are available for customer audit. We have extensive pharmaceutical and technical experience and can match the specific needs of each customer’s project with the expertise of a qualified supplier. We can also offer practical industry experience in dealing with FDA regulations, in-house regulatory support, synthetic route development, and assistance with process development.

Pharamacutical Consulting

DEVELOPMENT

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

APPLICATION

Filing & Managing all of the Processes for FDA Drug Applications

COMPLIANCE

FDA and Global Regulatory Compliance and Submission

MANUFACTURING

Complete Facilities Design from inception to full FDA qualification

Comments are closed.