worldwide

Solutions for Regulatory Compliance

No matter if you are selling your products internationally or only within one region, regulatory compliance should never be a “Terra incognita”.

knoell Solutions for Regulatory Compliance

With our global network of affiliates, knoell keeps track of the continuous developments concerning global regulations related to Crop Protection & Nutrition,Biocontrol, Chemicals, Biocides, Medical Devices, Animal Health Products, Cosmetics as well as Food Contact Materials. We support our clients with most suitable and efficient strategies to ensure compliance in multiple target markets.

 

Common questions we CAn Answer for you

  • Which regulation applies to my product in country X?
  • Which regulatory strategy is the best to gain market access?
  • What is the best approach for my risk assessment and the best way to present my data?
  • Do the available data meet current regulatory requirements?

 

What knoell can do for you

  • Scoping
    We provide you with the latest information on the regulatory landscape in your target market.
  • Impact Assessment
    We explore the impact of the applicable regulations on your product portfolio and check if there are any compliance issues.
  • Monitoring
    We review any regulatory changes and evaluate the need to update the Impact Assessment.
  • (Re-)establish compliance
    Based on the Impact Assessment we develop appropriate registration and testing strategies including alternative non-testing approaches, such as (Q)SARs and other in silico methods. Depending on your product and market, quite often there is more than one path for obtaining registration. As your competent partner we can develop a regulatory strategy, either for a certain country, region or on a global level, in order to achieve the most efficient access to your key market(s).
  • Submission support
    for Europe, China, Taiwan, Korea, Japan, ASEAN countries, USA, Canada, Australia, South Africa, LATAM and others incl. local representation (for details, please check our Solutions and Locations sections).