Regulatory support & customer-oriented solutions FOR YOUR AMINO ACIDS AND FORMULATIONS

Evonik is not only a preferred supplier or amino acids, but a global development partner and solutions provider with strong regulatory expertise

Evonik is far more than just a preferred global supplier of high purity amino acids, derivatives and peptides. We also serve as a development partner and solutions provider to many of the world’s pharmaceutical, biotech and nutraceutical customers. Our broad mix of core competencies across chemistry, biotechnology, drug delivery and cell culture uniquely position us to create long-term value for you, as well as the patients and consumers that depend upon your products. If you require regulatory support or individual solutions as amino acids customer, our team can support you in a range of areas from analytical testing to packaging. Many customers also leverage our decades of drug delivery expertise to help them in the formulation development and scale-up of their products.

Explore our range of customization and regulatory services for high purity amino acids

Our solution-oriented experts in production, quality and regulatory can help you to address specific property or combination requirements. For particle design, we can help to tailor particle size distribution at a consistent target level between one and 1,000 microns, as well as modifying other factors including shape and crystallization structure. Furthermore, we also have several decades of experience in the purification of our amino acids at any scale via the use of proven chromatographic technologies. These and other customization solutions are supported by the best available analytical services, including the development of analytical methods, to help you precisely define the composition of an amino acid mixture, or the by-product composition of an amino acid derivative. Our in-depth process knowhow combined with extensive range of customization and regulatory service options can help to ensure you receive your ideal product at the highest levels of quality and consistency.

Regulatory services for amino acids that can help you to reduce project risk and accelerate speed to market

Our priority is to help you minimize risk and accelerate speed to market for the introduction of your products across international parenteral nutrition and other markets. That is why we provide customers with an extensive range of regulatory services for amino acids. These regulatory services are underpinned by our strong local knowhow of regulatory processes and regulations across many countries and regions worldwide. These regulatory services for amino acids include REACH registrations, as well as support in the creation and maintenance of Drug Master Files (DMFs) and various certifications. Furthermore, we can help you to navigate regulatory requirements for different product grades including ICH/Q7A, ISO 22000, HACCP, Halal and Kosher, and also proactively prepare for the implementation of new regulatory requirements.

Beyond amino acids, leverage decades of industry leadership in the formulation development and scale-up of pharmaceutical drug products

In addition to the supply of amino acids, derivatives and peptides and other pharmaceutical and food ingredients, we have also been one of the world’s leading development and manufacturing partners for oral and parenteral drug products for more than 40 years. These formulation development and scale-up services, together with our global network of laboratories, are available to support you in the creation of differentiated products in various colors, flavors and forms that are preferred and strongly accepted by patients and consumers. Our formulation development services can originate with the rapid completion of initial feasibility studies and extend all the way through to large-scale production transfer of the commercial product. To further support your quality, development and regulatory submission processes, comprehensive data packages can also be provided as service to our amino acid customers.