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Range of Services
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. Our staff's experience includes the following:
Biocides, Agricultural Chemicals, Insect Repellents, Pesticide Products
- Development of regulatory strategies and representation at EPA
- Dossier preparation for Federal, State and International registrations
- Tolerance petitions
- Emergency exemptions
- Labeling development, preparation, and review
- Data compensation appraisals
- Product stewardship and defense
- Literature searching and regulatory review
- Study design and protocol development for testing programs
- Study placement and monitoring
- Development of alternate testing strategies including computer modeling
- Environmental, occupational, and dietary exposure and risk assessments
- Technical support to industry associations, task forces, and REACH-formed SIEFs
Food, Nutritionals, Drugs, Devices, and Cosmetics
- Labeling development, preparation, and review
- Product stewardship and defense
- Safety evaluation of product packaging and delivery systems
- Electronic submission of establishment registration and drug listing via structured product
labeling (SPL) via FDA's Electronic Submissions Gateway
- Literature searching and OTC monograph compliance review
- Study design and protocol development for testing programs
- Study placement and monitoring for chemistry and pre-clinical evaluations
- Development of alternate testing strategies including computer modeling
- Development of expert opinions and Citizen's Petitions supporting pharmaceutical active
ingredients and products
- Expertise in OTC and prescription drug regulatory affairs, strategies, and submissions -
Rx-OTC switch, NDA, sNDA, dNDA, and IND submissions
- Extensive experience across multiple drug therapeutic categories especially ocular and
upper respiratory
Industrial and Specialty Chemicals
- PMN and Exemption (LVE, LoREX) notification guidance, preparation and submission
- Notice preparation via eTSCA computer-based application and coordination of electronic
submission through EPA's Central Data Exchange (CDX)
- Literature searching and regulatory review of candidate chemicals for intended chemical
manufacture or importation
- Study design and protocol development for testing programs
- Study placement and monitoring
- Development of alternate testing strategies including computer modeling
- Environmental and occupational risk assessments
Litigation 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.
International Offices
toXcel's 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.
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