A great fit!

knoell in the USA

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.

knoell USA, LLC
3070 McCann Farm Drive I Suite 111   
Garnet Valley, PA 19060   

 The route to us

knoell USA, LLC
68 T.W. Alexander Drive I Alexander Business Suites
Research Triangle Park, NC 27709

 The route to us
Salley Feeley
Sally Feeley
General Manager, knoell USA
Jeff Sumpter
Jeff Sumpter
Sales Manager, knoell USA

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))

TSCA training courses

TSCA training courses

 

  • Export Notification (TSCA Section 12)
  • Import Certification (TSCA Section 13)
  • Polymer and R&D Exemptions
  • TSCA compliance reviews

TSCA Updates

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More on
TSCA

TSCA Inventory Notification (Active-Inactive)

Environmental Protection Agency published a pre-publication notice of the Final Rule reopening the TSCA Inventory Active-Inactive Reporting Period.

Changes to Fee Obligations for EPA-Initiated Risk Evaluations

US EPA published a notice containing the preliminary lists of manufacturers and importers of the 20 chemical substances that have been designated...

New chemicals under amended TSCA: Same process, different outcome

The main drivers for amending the US's Toxic Substances Control Act (TSCA) were the perceptions that not enough was known about the risk to human...

Medical Devices

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.

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knoell Medical Devices, LLC
1633 W Main Street | Suite 700 | Lebanon, TN 37087

 The route to us
Photo of Dr med. Isabelle Lang-Zwosta
Dr med. Isabelle Lang-Zwosta
Global Regulatory Affairs and Business Development Medical Devices

Animal Health

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.

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knoell Animal Health, LLC

3070 McCann Farm Drive | Suite 111 | Garnet Valley, PA 19060

 The route to us
Laura S. Treml
Laura S. Treml, VMD, PhD
Head, Veterinary Product Development USA

Updates from The US And Canada

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Join our talk

ACS FAll 2021

22 - 26 Aug 2021
in-person in Atlanta, USA & online

MD&M West 2021

10 - 12 Aug 2021
Anaheim, CA, USA

The medtech community's greatest event.

Animal Health Innovation USA

15 - 16 Jun 2021
online event

Meet us at the 5th Animal Health Innovation USA 2021