At Protheragen MedAI, we specialize in providing high-quality small molecule customized GMP manufacturing services. cGMP compliant manufacturing facilities, located in the USA and China, are dedicated to encompassing the complete lifecycle of drug production, from initial development through to large-scale manufacturing (mgs-tons). All sites boast a fully compliant cGMP laboratory and a multi-Kg scale cGMP commercial manufacturing facility. We specialize in:

Custom Synthesis Capabilities: Offering tailored synthesis solutions for complex molecules, from milligrams to tons at every stage ranging from Pre-clinical to Commercial Production.

Process: Feasibility Study & Planning→ Synthesis Development→ Analytical Methods Development→ Process Validation→ Impurity Isolation & Characterization→ Validation of Analytical Methods→ Pilot-Scale Production→ Commercial-Scale Production→ Stability Testing According to ICH Guidelines→ Quality Control Testing→ Documentation and Regulatory Submission→ Ongoing Stability Monitoring→Process Optimization.

Service Process

• Initial Consultation and Planning

Manufacturing process starts with detailed discussion to determine what your requirements are, like drug type, scale, and production time. Our engineers work with you to define the scope of work, technical specifications, and manufacturing plan. This first step is key to coordinating expectations and making sure all regulatory and quality issues are met at the beginning.

• Process Development and Optimization

Once the planning phase is complete, we proceed to process development. Our scientists and engineers work to develop a robust, scalable manufacturing process for your small-molecule drug. This includes optimizing the synthesis route and purification method.

• Scale-Up and GMP Production

We transitioned the optimized process to scale-up and GMP production. We are equipped with modern manufacturing lines from small-scale clinical trials to large-scale commercial production. We follow GMP rules throughout the manufacturing process to make sure that all records are kept and the quality of the product is consistent.

• Quality Control and Assurance

Quality is the guiding principle and tenet of our manufacturing service. We have strict QC and QA measures at every step of production. Each batch of our products goes through rigorous tests by our QC laboratory including raw material testing, process control and final product testing to guarantee the purest, strongest and safest. To maintain compliance with global standards, our QA department is responsible for compliance, documentation and regulatory submissions.

• Regulatory Compliance and Documentation

Drug manufacturing complies with regulations as a critical part of it. We're experts on regulatory bodies such as FDA, EMA, and ICH guidelines. We offer complete records such as batch data, analysis reports, and validation documents to be submitted to regulators. Our aim is to make sure that your products comply with all regulations and get market approval as soon as possible.

Our team of experienced chemists, engineers and regulatory experts is committed to providing strong support to our customers' drug development projects through our small molecule custom GMP manufacturing services. Our goal is to help customers achieve successful drug development through superior manufacturing services, and ultimately bring innovative and effective treatment options to patients. Contact us to see how our GMP manufacturing services can be used for your project.