Extractables & Leachables

Meet Rigid Standards with
Flexible Protocols

Effectively incorporate a risk-based approach to extractables & leachables studies (E&L) with the assistance of Avomeen’s consultative expert scientists who are well-versed in regulatory guidance and standards, advanced analytical technology, and interpretation of data.

Modular Approach with Rigorous Quality

Avomeen’s trusted modular, risk-based methods result in improved cycle times and decreased expense.

Our industry-leading experts with decades of industry and laboratory experience work directly with your team to ensure data is presented and reviewed throughout the course of the study. Together we will act as an extension of your team and guide you through the evaluation process while consulting on alternative approaches when necessary. Learn more about Avomeen’s modular E&L approach by reading our whitepaper.

Put our modular approach to the test

Unrivaled Scientific Expertise

Avomeen’s accomplished scientists have exceptional pride in their ability to expertly design and deliver extractables & leachables studies while drawing from their breadth of expertise, which extends to an array of diverse disciplines within the Life Sciences. Our E&L chemists specialize in:

  • Extractables screenings and profiling
  • Developing routine extractables control methods
  • Controlled extraction studies
  • Method development and validation for leachables studies
  • Extractables and leachables evaluations
  • Ensuring drug product and container-closure system compatibility
  • Label migration studies
  • Risk based methods

Avomeen Ph.D. scientists will work with you to develop a customized testing protocol and address requirements for pharmaceutical packaging, medical device registration, and label migration studies according to regulations including:

  • USP 661/661.1/661.2/662
  • USP 1663
  • ISO 10993-12 for medical devices

Why Partner with Avomeen?

Decades of experience, the capability to tailor protocols and E&L 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.

Industry Leadership

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.

Ph.D.-Backed Projects

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.

Technical Tenacity

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 and consultation to your ever-changing needs.

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Ready to Partner? So are We.

Request a quote or ask an experienced scientist today.