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Process Development Service
FromCeutical Labs
Ceutical Labs has experienced personnel to assist in the development of parenteral, topical, and oral dosage forms. We can develop and fully document the entire production process. We have developed many products across most therapeutic classes.
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- Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients
- Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches
- Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized
- Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life
- Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency
- Establish validation procedures for manufacturing processes
- Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size
- Provide for orderly scale-up to full production volume to assure that the product can be manufactured efficiently. Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias.