PROFILE: Dr. Knoell Consult GmbH
CONTACTS Website E-mail Head office Tel Fax Contact Directors
Dr Knoell Consult Ltd, Cardiff, UK Knoell Iberia SL, Madrid, Spain / Knoell Iberia SL, Lisbon, Portugal Dr Knoell Consult Shanghai Ltd, Putuo, Shanghai, China Dr Knoell Consult Schweiz GmbH, Basel, Switzerland Dr Knoell Consult Thai Co Ltd., Chiang Mai, Thailand Cyton Biosciences Ltd, Bristol, UK Critical Path Services, LLC, Garnet Valley, PA, US Critical Path Services, LLC, Research Triangle Park, NC, US Critical Path Services, LLC, Carrolton, TX, US Knoell France SAS, Lyon, France Knoell KK, Tokyo, Japan Knoell Korea Ltd, Seoul, Republic of Korea
www.knoell.com info@knoell.com Dynamostraße 19, 68165 Mannheim, Germany +49 (0)621-718858-0 +49 (0)621-718858-100 Dr Michael Cleuvers Dr Hans-Emil Knoell Dr Runar Eberhardt Torsten Hauck Dr Marika Suhm-Tintelnot Dr Michael Cleuvers Private company, majority-owned Germany, UK, Switzerland, the Netherlands, Spain, Portugal, France, China, Thailand, US, Japan, Korea 1996
Ownership Locations Founded OVERVIEW
We are a full service provider in global regulatory affairs for industrial/ specialty chemicals, agrochemicals, biocides, pharmaceuticals, veterinary medicine and medical devices. Additionally we offer a wide range of services in the field of product safety (eg preparation of (extended) safety data sheets, classification and labelling of substances and mixtures). We will work with you to ensure that your products are in compliance with the latest developments, not only in Europe (EU and non-EU), but also in the US, Canada, South America and the entire AsiaPacific region (China, Taiwan, Japan, Korea, Australia, and the entire Asean region). With a global network of subsidiaries and co-operation partners, we match our services to support your business needs. VITAL STATISTICS
2016/17
Turnover, group
> €60m
Turnover, chemical service provision
> €20m
Number of offices
17
Number of countries represented
12
Staff, group
approx. 600
Staff, chemical service provision
>180
SERVICE AREA BREAKDOWN IT & Training Laboratory software 5% 1% 5% Information 7%
Representation & management 20%
GLOBAL OFFICES Dr Knoell Consult GmbH, Mannheim, Germany Dr Knoell Consult GmbH, Berlin, Germany Dr Knoell Consult GmbH, Leverkusen, Germany Knoell NL BV, Wageningen, the Netherlands Page 126
Consultancy/advisory 62%
SERVICES PROVIDED Global registration of industrial and specialty chemicals Dossier preparation and submission: Iuclid 6 files for REACH, TSCA registration including PMN support, registration dossiers for Canada, Korea, China, Taiwan, Japan and the Asean countries. Toxicological and ecotoxicological hazard and risk assessment, exposure modelling, post-submission support, communication with authorities, OR- and TPR-services, and full consortia management. Data review and analysis: strategic advice regarding testing and registration strategies, in silico methods (Qsar), read-across and waiving strategies), literature searches, data evaluation, data gap analysis, and study monitoring. Product stewardship: classification and labelling under GHS, CLP, and Osha HazCom; development and management of safety data sheets (SDSs) and extended safety data sheets (eSDSs); supply chain management and communication; management and support of formulators and article manufacturers concerning regulatory compliance in their global markets. Global registration of agrochemicals and biocides Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness checks, study management and monitoring. Dossier preparation, biological efficacy, residues and metabolism, import tolerance dossiers, dietary safety, toxicology, human exposure, exposure modelling, PEC-reports, environmental risk assessment, ecotoxicology, study-monitoring and management of bee studies, endocrine disruptors and CADDY-dossiers. Medical devices, pharmaceuticals, cosmetics Classification of medical devices, support in CE-marking (class I, IIa, IIb, III including consultation), FDA clearance/authorisation (510(k), PMA), CMDR registration (CMDCAS), Taiwanese registration (TCP II, ISO 13485), Australian registration (TGA), biological safety assessment, review technical file, biocompatibility testing strategy and supervision of test (including justified waiving), material characterisation including toxicological evaluation, clinical evaluation, pre- and post market vigilance/safety, implementation and review of QM system (ISO 13485/MDD/IVDD/IAMD and/or QSR), review and preparation risk management file, auditing (internal, pre-regulatory, supplier), training. Non-clinical/ pre-clinical services for human pharmaceuticals (study management, toxicology, pharmacology, metabolism, pharmacokinetics, bioanalysis, biosafety testing), medical writing (eg expert opinions, study reports), registration of cosmetics (INCI-listing, labelling etc), food and food additives, food contact materials, registration of substances in contact with drinking water. Animal health products (pharmaceuticals, immunologicals, feed additives) Our animal health consultancy service provides specialist multidisciplinary technical expertise in quality, safety and efficacy, as well as regulatory affairs for a wide range of product types, for example pharmaceuticals (active substances and finished products), immunologicals, feed and feed additives, borderline products and general care products. We can assist clients at any stage of their project – from product development and clinical testing, through the authorisation procedure and to maintenance of product licences. Within the EU, we
Chemical Watch | Global Service Providers Guide 2017