Pranit Pharma

NORTH AMERICAN AND INTERNATIONAL CLIENTELE

toXcel is a world-class expert consultancy team dedicated to providing clients with the reliable scientific, technical, and regulatory support needed to obtain US and international registrations of plant protection chemicals and biocides as well as for approvals of pharmaceutical active substances, inert ingredients, adjuvants, and excipients. Our experience also includes comprehensive preparation of scientific position papers, dossiers, food and chemical safety assessments, and toxicological support for nonclinical pharmaceutical testing programs.

EXTENSIVE EXPERIENCE

toXcels highly experienced and multidisciplinary staff includes former senior government scientific and regulatory review managers, as well as regulatory affairs and R&D direc ...tors from industry. These leading consultants focus their collective professional talents to assist chemical manufacturers, formulators, pharmaceutical companies, health care/consumer product manufacturers and suppliers, trade associations, law firms, and the food industry.

FULL RANGE OF SERVICES

toXcel provides a full range of services to support regulatory approvals with emphasis on regulatory strategy development and all aspects of the preparation of applications and dossiers. This includes the performance of risk assessments, exposure analysis, safety and toxicological evaluations, and the design and management of GLP analytical chemistry, residue, efficacy, environmental fate, mammalian toxicity, metabolism/ pharmacokinetics (ADME), and ecotoxicity studies. Our staff also advises companies about compliance with REACH, BPD and other EU GATION AND ENFORCEMENT

toXcel professionals provide expertise and support to law firms representing clients in litigation involving product liability and toxic torts and enforcement actions. Individual consultants are experienced in due diligence procedures involved with mergers, acquisitions, and registration transfers; provide expert opinions for product defense; and serve as expert witnesses in scientific, technical, and regulatory matters before federal and state courts and arbitrations.

OFFICES

toXcels North American and European offices work closely together to provide a coordinated regulatory resource for seamless development and execution of strategies designed for cost-effective regulatory approvals leading to domestic, regional, and global export market expansion. Read more