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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.
Our Development Team Can:
- 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.
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