Intellectual Property & Regulatory

Improved Pharma has a great deal of expertise in intellectual property.  Improved Pharma has intimate knowledge of many important patent litigations involving polymorphs (Ranitidine and Paxil), salts (Norvasc, Plavix, Fosomax), nanoparticles, and several formulations (Evista, Clarithromycin, Prevacid).  Improved Pharma uses this knowledge to assist its clients in achieving the proper intellectual property at the proper time. 

Scientific basis of claims construction

Improved Pharma provides the scientific basis for patent preparation and claims construction. Improved Pharma works with top IP law forms in the preparation of strong patents.

Formulation

Formulation patents, if properly constructed, can be strong. Improved Pharma uses its expertise in formulations, stability and solid state chemistry to ensure the he best possible formulation patents are prepared.

Solid State Chemistry

In the broadest sense, solid state chemistry underpins most of the best patents on polymorphs, salts, and amorphous forms. Improved Pharma is a leader in solid state chemistry and uses this expertise to assist its clients in gaining strong intellectual property.

Stability

During the solid form screening, extensive stability studies under accelerated and forced degradation conditions are performed. These studies focus on both chemical and physical stability of the solid form. Improved Pharma has a strategy using a minimum of experiments to obtain information on the stability of clinical supplies for the clinical study. These stability studies are used to select the form for manufacture into clinical supplies. This information is then used to develop strong intellectual property.

Solubility

For salts, cocrystals, or amorphous forms it is possible to gain substantial improvement in solubility by using the proper solid form- typically a salt, cocrystal, or amorphous form. Improved Pharma's strategies are superior for poorly soluble compounds. Because of these strategies, the intellectual property resulting from this work is typically strong and suitable for defensible patents.

Regulatory & clinical trial support

Improved Pharma's template-based system insures the highest quality regulatory submissions. These submissions are checked for quality by an independent party prior to release. Improved Pharma works with only the top clinical trial providers.

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....