knoell Germany GmbH of Mannheim at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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knoell Germany GmbH

Konrad-Zuse-Ring 25, 68163 Mannheim
Germany
Telephone +49 621 718858-0
Fax +49 621 718858-100
info@knoell.com

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Hall map

MEDICA 2021 hall map (Hall 10): stand G32

Fairground map

MEDICA 2021 fairground map: Hall 10

Our range of products

Product categories

  • 07  Medical services and publications
  • 07.01  Reports and analyses

Reports and analyses

  • 07  Medical services and publications
  • 07.04  Education

Education

  • 07  Medical services and publications
  • 07.10  Consulting services for health organisations
  • 07  Medical services and publications
  • 07.17  Other medical services and publications

Other medical services and publications

Our products

Product category: Consulting services for health organisations

Strategic & Regulatory Consulting

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”.

With our global network of affiliates, knoell keeps track of the continuous developments concerning global regulations related to Crop Protection & Nutrition, 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 chemical compliance in multiple target markets.


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, Brazil, South Africa and others incl. local representation (for details, please check our Solutions and Locations sections).

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Product category: Consulting services for health organisations

Document Preparation & Submission Support

Worldwide registration
Chemicals, Crop Protection, Crop Nutrition, Biocides, Medical Devices, Animal Health, Food Contact Materials, Consumer Goods or Cosmetics: knoell can support you in all phases of registration and authorisation in your target markets.

For a successful and efficient submission you need the right communication, the right tools and the right people. Our in-country registration managers ensure smooth communication with authorities and agencies and support with all application forms and documents that need to be submitted, in addition to the technical core information.


Registration Management
  • Consortium and Task Force Management
  • Support with data sharing and Letter of Access (LoA) negotiations
  • Interaction with authorities and notified bodies pre- and post-submission (i.e. representing clients at authority meetings, handling submissions, applications and notifications) as well as with CROs and actors within our client's supply chain
  • Specific Representative services (e.g. as Only Representative in EU, UK, South Korea, Sole Representative in Switzerland, Local Agent in China, or TPR in Taiwan)
  • Local in-country submission support via knoell offices or our trusted cooperation partners

Document preparation
The amount of documents that need preparing in the course of the registration/authorisation process can appear endless. At knoell, we can support you with preparation of...
  • Dossiers
  • Technical reports
  • Study summaries (e.g. OECD format)
  • Tolerance Petitions
  • Declaration of Compliance / Conformity (DoC)
  • Expert statements and opinion letters
  • Label finalisation
  • Application and submission forms
...and everything else you require for your submission; taking the pressure off you and freeing your capacities.


We also take care of the basic administrative tasks:
  • Formatting
  • Electronic submission (e.g. IUCLID, R4BP, CADDY, VNeeS)
  • Printing
  • Shipping
We support you not only with document preparation in English, but can also prepare required documents in many other languages due to the international nature of our teams.

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Product category: Consulting services for health organisations

Hazard, Exposure & RIsk Assessments

Because of our many years of experience in human and environmental safety assessments and our global outreach, knoell is perfectly positioned to provide a broad spectrum of services for registration packages in Europe and beyond.

With a team of nearly 40 toxicologist, more than 70 environmental fate and modelling experts as well as approximately 45 ecotoxicologists your assessments are in expert hands.


Standard and higher tier approaches
When it comes to the use of chemicals, human, environmental and ecological safety are key. Therefore, depending on the active ingredient, product and country of use, complex assessments form the core of most sets of documents required to obtain and maintain market access.

Standard assessments are calculations based on conservative assumptions and simple equations. Calculations can be performed using Microsoft Excel spreadsheets, sometimes provided as a standardised 'tool' by the respective authorities, or slightly more sophisticated models (e.g. the FOCUS suite for EU groundwater and surface water modelling) but still using conservative input parameters. In contrast, higher tier approaches gradually increase in complexity with each tier of the models in order to depict the natural "real-life" conditions and possible effects as accurately as possible.


Computer based (in silico) modelS - QSAR, read-across, and more...
Years of experience in the various regulatory areas covering the different categories of chemical substances allowed knoell to establish a team specifically dedicated to developments and use of in silico models. For example the following tasks and questions can be supported by data derived from in silico models
  • Early screening can deliver results to support your decision making processes at an early stage of R&D of new substances.
  • Obtained information can supplement experimental data in weight of evidence approaches.
  • Data can be used in order to meet the 3Rs principle: Replacement, Reduction and Refinement of animal testing.
  • Testing of all metabolites (and impurities) is practically impossible e.g. due to timeline constraints and/or technical limitations.

Endocrine Disruptor (ED) assessments
Our team of experts supports in all aspects of the highly complex and challenging Endocrine Disruptor (ED) assessment, tailored to your needs.
  • Assessment according to ECHA/EFSA ED Guidance
  • Literature & database search, QSAR profiling
  • Weight of evidence, mode of action analysis
  • Development & design of testing strategies
  • Screening of biocidal product co-formulants
  • Training courses

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About us

Company portrait

KNOELL: YOUR GO-TO PARTNER FOR REGISTRATION - WORLDWIDE

Benefit from knoell‘s outstanding in-country registration concept where we combine scientific expertise with true understanding of the local authorities, culture and markets.


Our strength is to be where it matters
Are you a company in the crop protection or crop nutrition industries, or doing business in chemicals, cosmetics, animal health products, medical devices or related markets?
Then we are there to support you to gain and maintain marketability of your substances, active agents and products - globally!

As one of the leading service providers for worldwide registration and regulatory compliance knoell offers you efficient services, high flexibility, excellent quality and reliability; always keeping in mind your priorities.

Benefit from our so-called 'glocal' concept, where we combine global know-how with local experience and intercultural competence. Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are taken into account right from the project outset to support your global business.