CMC Experts Provide a Complete Solution
Avomeen is an experienced CMC contract research organization (CRO) with a proven track record of taking on and expertly delivering the most complex and analytically challenging pharmaceutical stability testing programs. Where other laboratories fail with unique APIs and challenging matrices, we succeed.
Our team operates in an environment of high compliance and is remarkably skilled at taking on all aspects of product stability including characterization of degradants, stability data trending, and ICH Q1A-F stability requirements.
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Proven Success in Meeting Unexpected Challenges
Our expert team is exceptionally skilled at taking on extraordinary chemical analysis tasks including the complex challenges that frequently arise throughout the course of a stability study.
Beyond expected standards, life science companies serving the pharmaceutical industry need trusted and accredited organizations upon which they can rely to develop and validate analytical methods for their entire portfolio of products without fail.
It is for this reason that Avomeen has become the trusted partner in ICH stability testing for a number of leading organizations. Our clients not only depend on Avomeen’s flexibility and technical expertise, but also the consultative, consistent communication between our Ph.D. scientists and your team throughout your project.
Put our Experts to the Test
Unmatched Quality and Compliance
Avomeen’s stability chambers are monitored 24/7 by automated systems which enables us to monitor products in an organized and controlled environment, and our FDA compliant stability testing protocols help determine expiration dates, provide recommendations on storage conditions, and testing intervals with Bracketing and Matrixing Designs.
Market-ready pharmaceuticals and therapeutics require GMP stability testing to comply with regulatory requirements. Thorough testing can also yield added value through:
- Improved product quality
- Shortened time to market via accelerated stability testing programs
- Insight into potential degradation tendencies
- Verification of compatibility among formula ingredients and packaging
- Stability testing across a range of conditions
Biopharmaceuticals, medical devices, and other environment-sensitive products reach an ever-growing number of patients and consumers around the globe. Formulators, producers, and manufacturers must be able to comply with regulations and ensure their products will survive the environmental rigors of temperature, light, and time. We offer:
- Photostability – Exposure to light is inevitable, but we can help you monitor the effect of light on biopharmaceuticals and products over time. Learn more about our photostability capabilities.
- Ambient – Our teams will help you ensure that properly stored pharmaceutical products and therapeutics remain functional and effective.
- Accelerated Stability Testing– Testing to ICH-approved environmental conditions can reduce your time to market.
Our expert team and facilities at Avomeen are prepared to customize our approach and a stability program depending on the needs of your project.
Why Partner with Avomeen?
Decades of experience, the capability to tailor programs, protocols and study designs, and a readiness to take on complex and non-routine analyses results in our ability to offer a comprehensive, all inclusive-solution to our clients.
Our wide-reaching capabilities incorporate industry-leading knowledge and expertise in the biopharma research, formulation, and regulatory processes. We’ve been helping to improve healthcare and speed time-to-market working with leading therapeutics and medical devices.
Every Avomeen project is backed by Ph.D. scientists who specialize in the regulatory knowledge and scientific applications specific to life sciences. When you put your project in the hands of our specialists, you can trust your results reflect the unparalleled knowledge of our industry-leading scientific minds.
When routine testing laboratories don’t have the experience or qualified experts to take on a project, they pass it on to the next laboratory. When those projects come to Avomeen, they get done. Our unique blend of scientific, regulatory, and legal knowledge allows us to problem-solve from unusual angles. If it’s the right scope, we say yes when others say no.
The Avomeen Experience
We excel in building partnerships with our clients to ensure success in every stage of the development process from discovery to post-market, including life cycle management. Our dedication to our clients is apparent in everything we do. We work with you to tailor our processes to your program while maintaining scientific integrity and ensuring compliance to regulatory requirements.
We’re Not Just Any Lab. We’re Your Lab.
We provide unmatched, complete solutions by working hands-on with you to tailor every test, protocol, stability program, and consultation to your ever-changing needs.
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Ready to Partner? So are We.
Start a quote or ask an experienced scientist today.