knoell in the USA
Crop Protection & Chemicals
Established in 2001 under the original name of Critical Path Services, knoell USA is a consulting company that serves the regulated scientific community. The company’s clients range from multi-national Fortune 500 companies to virtuals and start-ups. Our continued year-over-year revenue growth earned us a position in the INC 5000 for 2011 and a CRO Leadership Award in 2012. As part of the global network of knoell companies, we provide expertise when and where you need it, supporting you to move your business forward.
Experts in regulatory affairs, registrations, dossier services and technical writing, and quality assurance combine with scientists in toxicology, ecotoxicology, environmental fate, consumer safety, and more to form our team. In addition to regulatory strategy and end-to-end registration services, we offer support with any piece along the way, such as with biotechnology consulting, study direction and monitoring, and risk and exposure assessment. We work with various North American regulatory agencies to achieve desired outcomes for our clients, including EPA (under FIFRA and TSCA), PMRA, and CEPA.
Our TSCA Support For You
- Strategic advice on test rules (TSCA Section 4)
- Development of PMNs (TSCA Section 5)
- Reporting for the CDR (TSCA Section 8(a))
- Development of TSCA 8 (c) Compliance Program
- Reporting of Substantial Risks (TSCA Section 8(e))
Medical Device access to North America: our Medical Device subsidiary close to the medical device center of the United States with over 80 companies in Nashville, Tennessee. We are able to support you in gaining market access for your medical devices and in-vitro diagnostic medical devices (IVDs), and to assist in navigating the ever changing global regulatory landscape. Gaining access to the U.S. is key as the medical device market in the United States is the largest in the world. We support manufacturers of medical devices and IVDs with our extensive expertise at every point of the product life cycle; no matter if you want to enter or maintain access to this critical market.
knoell Medical Devices, LLC
1633 W Main Street | Suite 700 | Lebanon, TN 37087
The knoell group has offered Animal Health services in the US for many years. However, with the acquisition in early 2020 of Triveritas, a well known globally recognised animal health contract research organisation, it made sense to establish a dedicated presence in the US. With staff working from within the Kansas City Animal Health Corridor, knoell Animal Health is located in the same area as many of our clients.
knoell Animal Health provides regulatory and clinical trials expertise and services to support companies developing biologics and pharmaceuticals for veterinary use in the US. Building on the strengths of fellow animal health members of the knoell family of companies, knoell Animal Health offers a full portfolio of services, including start-to-finish product development and ad hoc services. With established clinical teams in the US and Europe and over 750 years of animal health experience, knoell Animal Health is able to seamlessly coordinate projects in multiple geographies, from proof of concept to registration and beyond, balancing the pillars of quality, time, and budget.
knoell Animal Health, LLC
3070 McCann Farm Drive | Suite 111 | Garnet Valley, PA 19060