Fabricación de Pastillas
We offer technical resources, capacity determination, flexibility, and the experience to develop and manufacture tablets with strict quality compliance. We partner with our clients and network of experienced tableting specialists to provide expert scientific resources throughout the manufacturing process. We are a small-scale, personal contract tableting manufacturer, focusing on full development support for customers with small-scale manufacturing needs. Our commitment to quality will keep your tableting manufacturing project on time and on budget.
Strict Quality & Compliance Control
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.