VanderWel will lead sales and marketing efforts for the West Coast. He will leverage his local connections and help to raise PCI Synthesis’ profile among the West Coast’s vibrant community of emerging biotech and biopharma companies.
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"Everyone at PCI is continuously working to improve the quality systems throughout our organization. Our efforts and investments in our facilities, training and new technologies, have been validated by another successful FDA inspection. More than that, the latest PAI pre-approvals further substantiate that our team understands the complex dynamics of small molecule development, including manufacturing, process optimization, scale up and comprehensive analytical support," said Edward S. Price, President of PCI Synthesis. "The focus on product approvals and approved APIs is part of our commitment to full scale R&D, which further positions PCI as an innovative CMO."
A job opportunity at PCI Synthesis may be right around the corner
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NEWBURYPORT, MA--(Marketwired - Sep 18, 2013) - PCI Synthesis, Inc. (), a custom chemical manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients (API), and other specialty chemical products, announced the completion of the sixth inspection of the company's cGMP site in Newburyport, MA by the FDA.
PCI Synthesis' cGMP facilities in Newburyport
About PCI Synthesis
PCI Synthesis is a 15-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. A contract manufacturing organization (CMO), PCI provides small and mid-sized companies with expertise needed to manufacture complex small molecules to be used in both the branded and generic market. To learn more about PCI Synthesis, its proprietary APIs, and R&D, please visit .
PCI Synthesis - Newburyport, MA 01950 - …
When a manufacturer qualifies an analytical method, it is simply assessing that it is suitable for its intended purpose. It compares specific samples of the compound to a standard one to test its reproducibility. Many companies choose to conduct this process early in pre-clinical stages in order to the determine the feasibility of the API or generic compound. This process usually takes a little more than one week to complete, at a cost generally in the $12-15K range.
PCI Synthesis – Newburyport, MA
"The latest successful FDA audit validates the ongoing investments we have made in our people, our cGMP systems, our research, and to our continual process improvement. We have a smart team that understands the complex dynamics of small molecules, from making molecules, optimizing molecules, performing process improvements, and scaling up," said Edward S. Price, President of PCI Synthesis. "Our focus and commitment to R&D is paying off, with our sixth product pre-approval, which assures the company of a steady stream of products in the years to come."
PCI Synthesis Wins Best NCE Manufacturer in 2016
PCI, which provides small and mid-sized companies with access to expertise for the development and manufacturing of complex small molecules to be used as APIs, is currently involved in the development of four late stage products recently included in MM&M's "Pipeline 2011" list of top launch prospects.