US & INTERNATIONAL REGULATORY SUPPORT
Our staff have the skills and experience needed to assist our clients in compliance with U.S. and international regulation of pesticides, pharmaceutical, cosmetic, and chemical products and devices. We are experienced in obtaining registrations of plant protection chemicals, biocides, and repellants, as well as approvals of pharmaceutical active substances, inert ingredients, adjuvants, and excipients.
Our experience also includes thorough preparation of scientific position papers, dossiers, food and chemical safety assessments, and toxicological support for nonclinical pharmaceutical testing programs.
toXcel staff also provide expertise and support to law firms representing clients in litigation involving product liability, toxic torts, and enforcement actions. Our senior staff consultants are experienced in due diligence procedures associated with mergers, acquisitions, and registration transfers. They provide expert opinions in data compensation negotiations and serve as expert witnesses in scientific, technical, and regulatory matters.
Our staff provide a full range of services to support obtaining marketing approvals by governmental agencies, with an emphasis on developing regulatory strategies and managing all aspects of preparing applications and dossiers. This includes conducting toxicological data evaluations, exposure and risk assessments, 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 US EPA/FIFRA and TSCA, REACH, the EU Cosmetics and Biocidal Products Regulations, Classification, Labeling and Packaging (CLP), and other US and EU regulations and guidelines.
The documents linked below provide more information about how toXcel can support your needs as your regulatory consultant:
- toXcel Brochure
- toXcel Pharmaceuticals Brochure
- US Pesticides
- Customized FIFRA Workshops
- Reach 2018
- FDA Electronic Submissions Gateway (ESG) Support
- Toxic Substances Control Act (TSCA)
- EU Pharmaceutical Regulatory Services
- EU Cosmetics Regulatory Services
- CLP Regulation
- US Pharmaceutical Regulation
- Dietary Supplements and New Dietary Ingredients
- California Safer Consumer Products Regulation
- Competitive Intelligence
- Due Diligence Services
- Litigation Support (Toxic Torts)
- Generally Recognized as Safe (GRAS) Determination