Reference standards are required for regulated bioanalysis, and the quality and degree of characterization of the reference standard will depend on the stage of drug development. To evaluate if all requirements are met, it is important to understand the information provided within a reference standard certificate of analysis (CoA).

Altasciences can take your API from formulation to clinical supply release in less time by offering a variety of strategies to expedite liquid-filled capsule development for first-in-human studies.

Whether your challenge is tight timelines, minimal budget, or a limited supply of API, Altasciences will create a development program tailored to your needs.

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Robust planning early in drug development can save you both time and money. Altasciences' in-house pharmacokineticists and biostatisticians can work with you to build a robust strategy from the get-go. They are accustomed to managing complex projects with different partners, no matter the therapeutic area — your drug will be in expert hands.

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Altasciences in partnership with a number of not-for-profit organizations, is developing a quantitative serological assay for the detection of SARS-CoV-2 IgG antibodies. Using several different antigens to enable solutions, our partnerships will alleviate the supply and quality of reagents in order to support vaccine development.

We have the experience and know-how to support your preclinical and clinical vaccine development programs.

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