• Manufacture of lab-scale & clinical batches (phase-I and phase-II) of parenteral, intranasal, topical and other dosage forms

• Analytical method development, validation & release testing

• Microbiological method development, validation & release testing

• Formulation development/optimization of parenteral, intranasal and topical dosage forms

• Cleaning validation studies and methods development/validation

• Dissolution method development, validation & testing

• Antimicrobial drug product preclinical & clinical development & testing

• Stability testing (ICH/FDA)

• Licensed to handle/ test Controlled Drug Substances

• Lyophilization cycle development

• Sterile filter validation studies

• Container/ Closure integrity evaluation (physical & microbiological)

• Manufacture of lab-scale & small scale clinical, toxicology and stability batches of parenteral, intranasal, topical and other dosage forms

• Development and testing of novel drug delivery systems, medical devices and nutraceuticals

• Preparation of technical documents for regulatory submissions

• Provide assistance to resolve complex technical/ regulatory issues with the FDA

• Technology Transfers

 ©2007 Lewis King Laboratories AG.