Client-Centric CMC Support in an Ever-Evolving Regulatory Landscape
Avomeen’s Ph.D.-backed teams of pharmaceutical scientists provide chemistry, manufacturing, and controls (CMC) services for the development and manufacturing drug products through Phase IIa. Global manufacturers trust our expert scientists to provide industry-specific insight and thorough CMC consulting & lab services to develop and advance effective therapeutics and drug products, no matter their stage in the development process.
Our industry-leading scientists conduct preclinical testing to expeditiously move therapeutics and drug products through clinical development, formulation, and manufacturing. Avomeen’s consultative approach includes a dedicated team of scientists with the up-to-date regulatory knowledge needed to ensure speed to market. With a proven track record of overseeing all parts of the development and approval process, Avomeen is a sought-after partner for leading organizations that serve the Life Sciences industry.
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Supplement Your Team with our Experts
Preparing therapeutics and drug products for clinical trials is an elaborate process with constantly evolving regulations that becomes simple when you partner with Avomeen’s consultative CMC experts. Strengthen your development team by partnering with our pharmaceutical scientists who act as an extension of your development team and bring years of practical industry and lab experience.
Avomeen’s comprehensive CMC offerings include the development of clinical trial materials as well as the requisite manufacturing and testing services for the production of a wide range of drug delivery systems including tablets, capsules, solutions, semi-solids, topicals, APIs and drug substances.
Put Our Experts to the Test
Taking Customer Service to a New Level
Our standard of customer service is what other labs consider to be above and beyond. We work within your tight timelines, doing whatever it takes to meet your deadlines, including scheduling around-the-clock shifts, and our teams have gone so far as to drive hundreds of miles to hand-deliver APIs and finished product to clients.
Full-Service Analytical Support
Trust the experts at Avomeen to provide comprehensive analytical support to ensure drug development is optimized through every phase of development, including quality control testing and a suite of analytical services. Our nimble approach to complex and challenging APIs allows us to successfully deliver what other labs cannot.
Chemical analysis testing allows for the production of pure and safe materials through understanding the chemistry of the major and minor components in a substance. Avomeen provides unmatched material testing for chemical product development cases, allowing clients to identify components used in competing products or raw materials that have been discontinued.
We provide testing for organic and inorganic materials to help determine material failure and to test raw materials. Materials are tested with the following set of robust capabilities:
Full-Service CTM Manufacturing
Once substances pass clinical trials, Avomeen provides specialized manufacturing services for safe packaging and distribution.
Our chemistry, manufacturing, and controls services and production processes include:
- Blending and Homogenization
- Filtration, Granulation, Compacting, Mixing, and Filling
- Spray Drying
- Pellet (Bead) and Powder Encapsulation
- Powder Blending and Tableting
- Liquid and Cream Manufacturing
- Container and Closure Selection
- Scale-Up and Technology-Transfer
The following services are used for clinical supply services:
- Trial Batch Manufacturing
- Placebo Development
- Stability Storage
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.
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.
Consult with a CMC Specialist
Alongside providing thorough CMC and manufacturing services, our team of CMC experts offer consulting on effective solutions for the manufacturing of products as they move through each part of the development process. Chemists apply extensive knowledge of method development, quality control, elemental impurities, and more to help manufacturers quickly release products that are effective and safe for use.
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.
Start a quote or ask an experienced scientist today.