Tableting Contract Manufacturing

Our goal is to move quickly and efficiently from clinical development into cGMP manufacturing. Throughout the manufacturing process, we monitor and analyze results to ensure that your product is delivered according to specifications and regulations. Our cGMP-compliant contract manufacturing services are available for any formulation. Compliant with Title 21 CFR part 11, all data is 100% inspected and quality audited to ensure full manufacturing compliance. We follow the FDA guidelines and incorporate appropriate elements of process validation for manufacturing. Additionally, cleaning verification studies are conducted and documented as appropriate for each project. We also have the expertise and experience to package and label products to meet appropriate FDA cGMP requirements. At Germaine Laboratories, our manufacturing process development experience allows us to effectively scale formulations from small batch sizes to multi-kilo batches and transfer manufacturing processes to the client.