FDA and State of Tennessee Health Department Registered and Inspected for cGMP Compliance
FDA Registered for 503B Compounding with cGMP Quality Attributes
Rapid and Quality Turn Around for
- Comprehensive Sterile Formulation Solutions from Discovery, Preclinical to Clinical
Manufacturing
- Final Dosage Labeling and Packaging
- Full Service Analytical Methods Development and Validation
- Aseptic Fill and Finish in Vials, Prefilled Syringes and Cartridges
- Organic and Aqueous Media Lyophilization
- Particle reduction via Homogenization and Extrusion
- Capability to handle Potent/Cytotoxic Compounds
- Monoclonal Antibodies, Liposomes, Lipid Nanoparticles and Emulsions
- ICH Stability Studies; CTM Storage and Limited Distribution
Our mission is to help patients by expediting efforts to bring innovative, life-saving
medicines to market.
We stand at the forefront of quality, capability, flexibility, adaptability and client
satisfaction, helping universities, scientific communities and industries deliver
therapeutic advances to market that will improve the standard of care.
