Toxicity Consulting Program
Leadscope partners with several leading Toxicology Consultants. Should you need additional expertise, feel free to contact one our partners listed below. They have access to and are trained in the use of the Leadscope software, Toxicity Databases and (Q)SAR Toxicity Prediction Suites.
Dr David Woolley
PO Box 13550, Linlithgow, EH49 7YU
Tel: +44(0) 1506 844036
ForthTox is an independent, toxicological consultancy working in pharmaceutical and chemical development; we are located in Scotland. We offer two proprietary in silico models for prediction of toxicity: Leadscope and Derek Nexus and use other software, such as T.E.S.T., CAESAR and ToxTree as appropriate; we also have a licence for METEOR for prediction of metabolism, allowing cross-checking of metabolites for toxicity. The results of in silico evaluation are validated, where appropriate, by reference to reports for closely related substances or by read across to groups of related chemicals, depending on context and information availability. We have extensive experience with in silico and in cerebro evaluations and our reports have been submitted to, and accepted by, major authorities including FDA and EMA.
For Nonclinical Services contact:
Tel: 0044 (0)131 449 8875
ICON plc is a global provider of outsourced development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programmes that support drug development. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 38 countries and has approximately 13,380 employees.
Alpha-PreTox is an independent consulting company founded by Romualdo Benigni.
It provides computational predictive modeling services focusing on the assessment of genotoxicity of chemicals with in silico approaches (i.e. QSAR, Quantitative Structure-Activity Relationships, Read Across), in order to fulfill regulatory requirements such as REACH and ICH M7.
SAXOCON is a Danish company. We are privately held and partly owned by the Technical University of Denmark. We offer toxicological services to the pharmaceutical, biotech and medical device industries. Preferably, we work with you on an early stage of your project to mitigate toxicological concerns as soon as possible, but we are also able to help you with a toxicological assessment of your product at a later stage.
2800 Kgs. Lyngby
Phone: + 45 40 11 20 27
SAXOCON are expert users of Leadscope and can develop customized QSAR models in Leadscope based on proprietary customer data. SAXOCON offers services that are compliant with current regulations in our toxicological assessments.
SAXOCON has since the beginning of introduction of ICH M7 delivered screening and expert evaluations for the Pharma industry.
Azierta is a consultancy firm that specializes in Science and Health with a strong expertise in Toxicology and Occupational Health & Safety, current Corporate member of EUROTOX. We have an exclusive team of accredited toxicologists which provide tailor-made solutions according to client's needs (times and budgetary constraints) to pharmaceutical, cosmetics, chemicals, biocides, medical devices and biotechnological industry.
Our services cover the entire product life cycle, from medical and regulatory support, to needs at toxicological, manufacturing and distribution levels, in addition to market access and pharmacovigilance. Through our expert and multi-disciplinary team, we collaborate with over 300 clients worldwide.
We are a result-focused team, that always prioritizes client needs and guided in our daily activity according to the formula that characterizes all our activities: quality, commitment, loyalty and flexibility.
Contact person: Javier Fernández
Bibra toxicology advice & consulting Ltd
Cantium House, Railway Approach
Wallington, Surrey, SM6 0DZ
Tel.: 44 (0)20 8619 0770
We have a simple aspiration, to provide the highest standard of chemical hazard and risk assessments across the broadest range of industries and government organisations. We aim to help our clients cope with the complex and ever changing regulations framed to protect human health, and we endeavour to do this in a way that meets their often challenging time and budgetary constraints. Perhaps our greatest strength is our level of experience, combined with a commitment to continuous education that is second to none. We doubt there is a more experienced and knowledgeable group of toxicologists working together in our field of expertise, in Europe. This, allied to the highest standards of customer service is why we believe, unequivocally, that we should be your partner of choice when your needs relate to any aspect of chemical toxicology. In summary, we are a business run by toxicologists, with a very simple philosophy: we will provide only the best of scientific help and assistance and will do so in a way that guarantees our support wherever and whenever you need it.
Contact person: Ashleigh Ace, Commercial Manager
S-IN - Soluzioni Informatiche Srl
Via G. Ferrari, 14
Tel.: +39 0444 1821160
Fax: +39 0444 1821169
S-IN Soluzioni Informatiche offers complete molecular informatics and QSAR services in compliance with the current regulations, e.g. REACH, CLP, ICH M7, BPR. Our team has a long-term experience of more than 10 years on the use of in silico (non-testing) methods in the regulatory context. We provide predictions for (eco)toxicological and physicochemical properties generated by different in silico methods, i.e. analogue approaches, statistical-based (quantitative) structure-activity relationships (Q)SARs and expert-rule based systems. In silico predictions are provided employing both commercial software (Leadscope, ACD/Labs Percepta) as well as publicly available software (Toxtree, Vega, T.E.S.T., ECOSAR, EPISuite, OECD QSAR Toolbox and CAESAR). When possible, we employ different tools in order to apply a consensus approach and thus enhance the reliability of the predictions. We also support customers with consulting and training services on how non-testing methods can be best applied within the regulatory framework.
SafeBridge is a unique team of toxicologists, industrial hygienists, and analytical chemists providing professional consulting services and analytical support to U.S. and international clients primarily in the greater pharmaceutical industry (including biotechnology and fine chemicals). With significant experience in product safety and occupational toxicology risk assessment, our toxicologists perform computational predictive toxicology assessments using Leadscope® and Derek Nexus; establish acceptable (permissible) daily exposure and occupational exposure limits; and provide toxicology testing guidance (study design and study monitoring) while employing rational and scientifically sound approaches that are consistent with the state of the art. We are equipped to help our clients safely manage their active pharmaceutical ingredients, chemicals, intermediates, impurities, and extractables and leachables, from the laboratory bench to the patient.
Toxicology Knowledge Team Sweden AB
SE 151 85 Södertälje
Tel: +46-(0)8-553 251 24 alt. +46-(0)8-553 251 25
The founding principle of Toxicology Knowledge Team's business strategy is to offer each client access to all of our combined expertise and problem solving abilities, in a tailor made fashion. Our staff have extensive experience in safety assessment of potential drug targets, an important component of early stage drug discovery projects. We also support companies that have more advanced pharmaceutical projects with design, monitoring and review of outsourced toxicology studies, as well as the generation of regulatory documentation.
Our in silico toxicity prediction services combine expert judgment with predictions from both proprietary models (Leadscope, DEREK) as well as publicly available software (e.g. the OECD QSAR Toolbox and CAESAR).
With headquarters in the greater Philadelphia area, PharmaFacts functions very much in a 21st century virtual mode, bringing together over 30 industry experts from all over the world, on an as needed basis, to partner with you in the facilitation and conduct of your entire Drug Discovery/Development Program. PharmaFacts specializes in partnering and facilitating the conduct of all aspects of preclinical drug development and IND-enabling studies, from Discovery to the Monitoring of Preclinical Trials to the Report Generation and Development Team Activities to the Management behind it all. Companies can then meet their schedules and workloads, take advantage of the latest technologies, adhere to GLP and regulatory guidelines and successfully meet your milestones.
Lisa D. Beilke, MSPH, PhD, DABT
Toxicology Solutions, Inc.
Toxicology Solutions is an independent consulting company focused on providing small molecule toxicology services to the pharmaceutical industry. Specialty services include in silico toxicity predictions using 3 major predictive software programs (Leadscope Model Applier, DEREK Nexus, and MultiCase).
Computational Toxicology Services offers a cost effective solution for pharmaceutical and chemical industry clients with toxicity screening needs that do not justify the investment in QSAR software, database modules and staff required to carry out independent computational toxicology screening. SciQSAR (MDL-QSAR), LeadScope and Derek predictive modules are available for the major toxicology studies necessary for the marketing of pharmaceuticals and food contact substances in the US and internationally and are currently being used as decision support tools for safety assessment by the FDA (1-5). The Computational Toxicology Services modules contain information derived from public sources and available under the freedom of information act.
Toxicology Consulting is an evaluation and communication process employed to convert technical toxicological data into useable knowledge which is then applied in the management of chemical risks.
Paul J. Kruzich, PhD, DSP, DABT
Aclairo Pharmaceutical Development Group, Inc.
1950 Old Gallows Road, Suite 300
Vienna, VA 22182
Telephone: +1 703-506-6760 ext 314
Our mission is to make clear the proper path for development of drug products; and to help implement this path with superior scientific and regulatory advice.
exeResearch is an independent research company providing computational chemistry and biochemistry research assistance to those in academia and industry. We help scientists without the resources, time, or knowledge to complete the needed computational aspects of their research projects.
Raymond A. Cardona, Ph.D., DABT
ChemTox Consulting, LLC
34 Pilgrim Lane
Naugatuck, CT 06770
CTC is an independent consulting company specializing in domestic and global issues in the areas of pesticide toxicology, risk assessment, product registration and regulatory affaris. Computational models, such as Leadscope, and expert opinion, are provided to expedite discovery and new product development programs. In silico environmental fate and aquatic toxicity modeling is also available. Prediction of a compounds potential toxicity and evironmental fate facilitates lead candidate product optimization and selection.
Prof. Dr. Klaus Kümmerer, CEOO
Martin Luther Straße 1
Telephone: +49 (0) 7644 / 32 87 84 9
Mobile: +49 (0) 162 / 27 36 46 7
EDC is an experienced and competent partner for the evaluation of existing chemicals and the targeted design, improvement, and optimization of chemicals and active pharmaceutical ingredients. For this purpose we use computer-based methods for the calculation of substance properties, targeted research and experimental expertise.
Ronald D. Snyder, Ph.D
Telephone: (973) 347 3075
Specializing in Genetic Toxicology evaluation and issue resolution based on more than 25 years in industry leadership roles with responsibilities for Discovery and regulatory Genetic Toxicology programs. Particular strengths include mechanism-based genotoxicity assessment and in silico analysis using Leadscope, DEREK and VITIC.
We also offer manuscript copyediting prior to or after journal submission. This service provides a grammatically-correct document as well as, if requested, a high level assessment of the Science; are all the data there to substantiate the conclusions drawn by the authors.