Collaborating for Success Tips for Improving Partnerships Between QA and Clinical Operations at Your Site

Risk-Based Auditing and its Application to GLP Computerized System Validation Procedures

Insights for Optimizing Your Preclinical Formulation and Drug Product Manufacture


 

Setting the Stage for Success

​​​​In this issue of The Altascientist, we explore critical considerations for formulation development and manufacturing for preclinical testing.

​​​You'll discover strategies employed by our experts to support your projects, as well as a case study.

​​​Topics covered include:

    •   e-formulation studies
    •   biopharmaceutical assessments
    •   steps in preclinical drug product manufacturing
    •   quality control procedures
    •   regulatory aspects
    •   risk management

Considerations to achieve optimal preclinical formulation and drug product manufacture

 

Ready to discuss your pharmaceutical formulation and manufacturing needs? Send us a message.

Related resources that may interest you:
    •   Webpage: Comprehensive Drug Development, Manufacturing, and Analytical Testing Services
    •   Podcast: Key Considerations When Formulating APIs for Preclinical Testing
    •   eBook: Maximizing Formulations for First-in-Human Trials

Looking to Reshore Your Drug Development Program?


 

Addressing the Biosecurity Act—A Network of Sites That Works for You

As geopolitical uncertainties still linger following the report of the Biosecurity Act, numerous pharmaceutical and biotech firms are prioritizing stability by reshoring their R&D outsourcing. Altasciences, with our nine facilities spread across the United States and Canada, is ideally positioned to meet your requirements.

Our network includes:

    •   preclinical facilities in Seattle, Sacramento, Columbia (MO), and Scranton;
    •   clinical units in Los Angeles, Kansas City, and Montréal;
    •   bioanalytical laboratories in Seattle, Columbia (MO), and Laval; and​​​​​​
    •   manufacturing facility in Philadelphia.

Discover more about each of our strategically located sites and how they can support your drug development programs.

 

Related resources that may interest you:
    •   Webpage: Altasciences’ Early-Phase Drug Development Services
    •   eBook: Regulatory Comparisons for Starting FIH Clinical Trials
    •   eBook: Advantages of Conducting Clinical Trials in Canada


 

Strategies for Safe and Timely Shipments


 

Your Samples Are in Good Hands With Us!

From regulatory precision to preserving sample integrity, shipments can be challenging. Let us navigate and mitigate these challenges for you with a team of logistical experts to:

      •   Streamline regulatory compliance through optimized documentation practices.
      •   Prioritize secure, temperature-controlled shipments with reliable couriers.
      •   Ensure your samples maintain their integrity with temperature monitoring, robust packaging, and contingency planning.
      •   Our tailored concierge-style sample shipping ensures your test materials reach the correct destination safely and on time.

Sample Logistics

You may also be interested in the below resources:

Fact Sheets

Sample Kits
Bioanalytical Services

Webpages

Bioanalytical Services
Clinical Services
Preclinical Services


 

 

What does change in drug development look like?


 

Disrupting the CRO Model:
A 2024 Global Health Summit Documentary

Can the drug development industry change for the better?

In a short documentary for the 2024 Global Health Summit, your partners at Altasciences lead the conversation on change in a slow-to-change industry. We dive into the obstacles and inefficiencies of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative outsourcing model that can help you bring better drugs to people who need them, faster.

Watch Altasciences in "The Shape of Progress"

Shaping progress in the drug development industry: A short documentary

Shaping Progress in the Drug Development Industry: A Short Documentary for the 2024 Global Health Summit

Be a part of driving change in global health by safely accelerating your early-phase drug development with Altasciences’ integrated model. Contact us to get started!


What is the Global Health Summit?

The Global Health Summit will be hosted alongside the WHO’s 77th World Health Assembly in Geneva this May. Leading up to the Summit is a series of interviews and documentaries about how the private sector can help drive global health in a positive direction. The campaign highlights several organizations pioneering developments within the healthcare sector. Altasciences is proud to participate in this year’s campaign.

Discover the series.

 

Reuters: Flipping the Drug Development Industry on Its Head

Altasciences is leading the conversation on change in the drug development industry as part of a new documentary series for the 2024 Global Health Summit, hosted alongside the WHO’s 77th World Health Assembly in Geneva in May. The mini documentary explores transformation in the slow-to-change drug development industry.

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