USP <661> and <662> Regulatory Compliance

Regulatory Expertise

Rely on the regulatory expertise of Avomeen’s consultative scientists to guide you through USP <661> Plastic Packaging Systems and Their Material of Construction, and USP <662> Metal Packaging Components and Systems imminent regulations. Our team’s ability to tailor processes to the needs of your project allows our expert scientists to ensure compliance not only with basic material characterizations per USP <661> and USP <662> but also advanced Extractables and Leachables characterization by USP<1663> and <1664>  for polymeric plastic  container-closure and drug products respectively for life sciences industries.

We Have Mastered the Most Rigorous USP <661> and USP <662> Challenges

As Avomeen’s regulatory specialists guide our clients through USP <661> and its subchapters USP <661.1> and <661.2>, our Ph.D.-led teams stay up-to-date on all regulatory guidance, including diligently preparing for and staying tuned for the imminent guidelines on metal packaging systems <USP 662> used in Pharmaceutical products. Our rigorous training and regulatory review practices ensure chemists and scientists company-wide maintain unwavering confidence in the analysis and consultation of biopharmaceutical and therapeutic plastic packaging.

Put our Experts to the Test

Ph. D. Led Teams

Ph.D.-led teams are prepared with testing techniques and rationale to consult on metal packaging testing for drug products and medical devices, due to our rigorous review of USP Interim Revision Announcements (IRA) and PF proceedings on USP <662>. Our analytical techniques and scientific talent assure comprehensive testing for safe and effective packaging.

Our Instrumentation Suite

The instrumentation suite at Avomeen’s labs consists of the most advanced  state-of-the-art liquid and headspace gas chromatographs coupled with mass spectrometers, HPLCs with PDA, RI, ELSD detectors and ion chromatography with conductivity detectors in addition to basic equipment such as autoclaves, ovens, muffle furnaces, potentiometric and volumetric titrators.

Why Partner with Avomeen?

Decades of experience, the capability to tailor 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.

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.

Staying atop USP <661> and USP <662> Changes

As rapidly as changes in regulations occur, Avomeen is faster and consistently reliable. As outlined in USP <661> and its subchapters USP <661.1> and USP <661.2> as well as the imminent USP <662>, we perform such analyses as plastic container-closure qualifications, metal packaging systems qualifications and leading identification and extractables & leachables testing.

Beyond testing & reporting, we also function as your regulatory consultants to help with appropriate Design of Experiments for your biopharmaceuticals, therapeutics, and medical devices.

We’re Not Just Any Lab. We’re Your Lab.

Our partnership doesn’t have to end when the project is complete. Our team values the relationships and trust we build with each successful client; it allows us to ensure success in every stage of analysis for products in the life sciences industries.

Dedication to client success is apparent in everything we do. Working with us enables you to tailor our processes to your program while maintaining scientific integrity and ensuring rigid compliance with regulatory requirements.

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Ready to Partner? So are We.

Request a quote or ask an experienced scientist today.