|
|
About toXcel
toXcel is a world-class expert consultancy team of scientists and regulatory affairs professionals dedicated to providing clients with the reliable technical support needed to obtain US, Canadian, European and other international approvals of regulated products. We provide full service and guidance on all aspects for registrations of plant protection chemicals, biocides, and insect repellents, as well as support for product development, regulatory approval and/or safety defense of pharmaceutical products, devices, personal care and consumer products, inert ingredients, preservatives, adjuvants, and excipients. Our experience also includes comprehensive preparation of scientific position papers, exposure analyses, food and chemical safety assessments, toxicological support for testing programs, labeling, and full preparation of dossiers for submission as required under the corresponding EU Directives.
toXcel's highly experienced and multidisciplinary staff includes former senior EPA scientific and regulatory review managers, as well as regulatory affairs and R&D managers and directors from industry. These leading consultants focus their collective professional talents to assist chemical manufacturers, formulators, pharmaceutical companies, law firms, trade associations, health care/consumer product manufacturers and suppliers, and the food and cosmetics industries.
toXcel provides a full range of services to support regulatory approvals with emphasis on regulatory strategy, development and all technical and administrative aspects of the preparation of applications and dossiers. This includes the performance of risk assessments, exposure analyses, safety and toxicological evaluations, and the design and management of GLP analytical chemistry, mammalian toxicology, efficacy, metabolism/ pharmacokinetics (ADME), residue chemistry, environmental fate, and ecotoxicity studies. Our staff also advises companies about compliance with REACh, BPD, 91/414/EEC, and other European regulations.
|
|