About Pci synthesis
Pci Synthesis: Your Trusted Partner for High-Quality Active Pharmaceutical Ingredients
Pci Synthesis is a leading full-service cGMP active pharmaceutical ingredients (API) contract manufacturing company that specializes in the production of new chemical entities (NCEs) and drug products. With over 20 years of experience in the industry, Pci Synthesis has established itself as a trusted partner for pharmaceutical companies looking to outsource their API manufacturing needs.
At Pci Synthesis, we understand that quality is paramount when it comes to API production. That's why we have invested heavily in state-of-the-art facilities and equipment, as well as highly skilled personnel who are dedicated to ensuring that every product we manufacture meets or exceeds our clients' expectations.
Our services include process development, analytical method development and validation, scale-up and optimization, cGMP manufacturing, packaging and labeling, stability testing, and regulatory support. We work closely with our clients throughout the entire process to ensure that their specific needs are met at every stage of development.
One of the key advantages of working with Pci Synthesis is our ability to provide flexible solutions tailored to each client's unique requirements. Whether you need small-scale production for early-stage clinical trials or large-scale commercial manufacturing for marketed products, we have the expertise and resources necessary to deliver high-quality APIs on time and within budget.
In addition to our core API manufacturing services, Pci Synthesis also offers a range of value-added services designed to streamline your drug development process. These include custom synthesis of intermediates and reference standards; impurity isolation/identification; chiral separations; solid-state characterization; particle size reduction/micronization; formulation development; preformulation studies; stability studies under ICH guidelines; regulatory support including DMF preparation/revision/submission.
At Pci Synthesis, we pride ourselves on being more than just a contract manufacturer – we are your strategic partner in drug development. Our team consists of experienced chemists who are passionate about what they do – delivering high-quality APIs that help bring life-saving drugs to market faster.
If you're looking for a reliable partner for your API manufacturing needs – one who can provide flexible solutions tailored specifically to your requirements – look no further than Pci Synthesis. Contact us today to learn more about how we can help accelerate your drug development program while maintaining the highest standards of quality and compliance.