5 services found
Ascendia Pharmaceuticals Services
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Special Development Programs
There is a wide variety of types of pharmaceutical research programs – complexity increases each year. Most programs today require special expertise of some sort, so finding the best CDMO for your project is important. Ascendia has experience working with many types of development projects. Our service expertise includes poorly soluble drugs, peptide formulations, animal health projects, early-stage parenteral products, complex generics, 505(b)(2) specialty products, nano-emulsions and nano-particles and high potency molecules.
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Formulations for Poorly Soluble and Low Bioavailability Drugs
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical ...
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Parenteral Formulation Development Services
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. Successful
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Nano Formulations Services
Nanotechnology is now being extensively utilized in the development of innovative drug delivery systems for various routes of administration. Due to the advantages of their targeted drug ...
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Biological Formulation Development Services
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a key position in the pharmaceutical market by revolutionizing treatments of several serious illnesses. In fact, ...
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505(b)(2) Product Development Services
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness reports on the drug product, but allows information required for NDA approval on safety and efficacy of the active ingredient ...