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Regulatory Guidance

Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria

Benefits of Liquid-filled Capsules

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.

Contact our Experts

Data that Meets Regulatory Guidelines Worldwide

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.

Start planning today!

  
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From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization

Podcast Speakers:

Steve Schweibenz, President, Manufactur

Altasciences Develops a Quantitative Serological Assay for the Detection of SARS-CoV-2 IgG Antibodies

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.

Contact us today

 

A Look at Driving Simulation Clinical Trials

Drugs that contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle require driving simulation clinical trials. In 2017, the FDA finalized a guidance that proposes a tiered approach to such studies, consisting of pharmacological/toxicological, epidemiological, and standardized behavioral assessments to evaluate possible drug effects on driving, starting early in clinical development.

Save Time and Costs with Liquid-Filled Capsules

Altasciences presents liquid-filled, two-piece capsule services to effectively formulate poorly soluble drugs and supplements, while reducing development time and costs. Liquid filling provides the ability to control R&D compounds, which are expensive and in limited supply.

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In this article, we explore key participant retention strategies in Phase I clinical trials.

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