Clinical Supplies

API - COA from US Firm

Improved Pharma has the capability of carrying out the synthesis of the API at foreign firms. However, our current plan is to manufacture drug product in the US and issue a Certificate of Analysis from that firm.

Molecular Basis of Manufacture

Manufacturing clinical supplies by filling a known solid form into capsules or a bottle is the ultimate in the molecular basis of manufacturing. The structure of the form is known and well characterized. In this case the molecular structure of the solid is used to control he release rate.

Control

Improved Pharma will typically develop a method to insure control of the solid form in the API and drug product.  This method will be easy to use and typically involves comparison of the observed pattern with a reference pattern.

Quality by Design

Improved Pharma's CMC strategies and its use of solid state chemistry insures quality by design even at this early stage of development. The molecular understanding of the dosage form forms the basis for complete quality by design based submissions. Contact Improved Pharma for more information or proposal in any of the above areas.

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Powerful methods of analysis including IVIVC

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Informatics system to insure quality documents

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Strong IP assigned to client

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Quality by Design for formulations

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Rapid assessment of the risk of stability problems

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Fast screening for the right solid form....