Home Up

Regulatory Affairs

 

 

ToxaChemica's staff has a detailed knowledge of the legislation and regulations governing foods, drugs, pesticides, industrial chemicals, nutraceuticals, and other regulated materials in North America, Europe and Japan.

ToxaChemica, International will provide scientific and regulatory advice and assist clients in gaining regulatory approval by complying the technical submissions in the areas of traditional food ingredients, direct and indirect food additives, secondary indirect food additives, feed additives, GRAS notification, GRAS self-affirmation, flavoring agents, colors, functional foods and nutraceuticals, pesticides, industrial chemicals, agrochemicals, human and veterinary pharmaceuticals, dietary supplement ingredients under DSHEA, herbal remedies, medical foods, genetically-modified foods, and consumer products.

Since 1990, our clients have benefited from our experience, expertise and professional judgment in achieving the objectives important to their programs: success, reduced time and decreased costs.

 

Our firm will assist clients in the following areas:

 
bullet

Regulatory strategy and program planning

bullet

Preparation of technical submissions and position papers

bullet

Liaising with regulatory agencies

bullet

Performing product safety assessments and scientific review         safety

bullet

Design, placement, monitoring, and evaluation of nonclinical studies

bullet

Organizing and/or participating on expert panels (GRAS panels)

bullet

Publication of toxicologic studies in the open literature

bullet

Expert testimony and litigation support

 

We have provided regulatory affairs support to over 100 industrial companies, trade associations and government agencies.

 

We have assisted the following organizations.

 

A.H. Robbins

Adria

Agri-Bio Corp

American Capital and Research Corporation

American Cyanamide

American Industrial Health Association

American Medical Systems

American Petroleum Institute

Apogee Research

Applied Environmental

Arrow International

Bio-Lab

Boehringer Ingeiheim Animal Health Inc.

Bonagria Technologies & Services

Booz, Allen & Hamilton

Bristol Meyers Squibb

Chemical Manufacturers Association

Chevron

Ciba-Geigy

Columbia Broadcasting Systems

Compu-Med Research Consultants

Consultox

Coopers Animal Health

Cydex

Delta Analytical Corporation

Dept of Agriculture

Dept of Labor

Disk Dynamics

Diverse Dimensions Art

Diversey Corporation

Donawa & Associates

Dupont Chemicals

E.R. Sqibb & Sons

Eka Chemicals

Eka Nobel

Elanco

Electric Power Research Institute

Eli Lilly

Environ Corporation

Expert Medical Witnesses

Expert Network

Farmacon

FMC

G. & G. International

Genentech

General Chemical

Georgia-Pacific

Gerber Products

Gillette Medical

H. Daniel Roth Associates

Hazelton Corporation

Helene Curtis Inc.

Herb Research Foundation

Hillyard Chemical

Hoffmann-LaRoche

ICF International

lntegra

Intota

Johnson & Johnson

Kevin Kennedy & Associates

Lewis & Harrison

Lithium Corporation of America

Longevity Enterprises

Lonza

Mary Kaye Cosmetics

Meeting Planning Associates

Merrill Dow Pharmaceutical

Metabolife

Milliken Chemicals

Minimed

Monsanto

Morilex Chemicals

National Food Processors Association

National Medical Advisory Services

Nature’s Bounty

NCH Corporation

Neurology Center

Nutraceutical Corporation

Ocean Spray

Perrigo

Rhone-Poulenc Ag

Physician Power Products

Phytos

Proctor & Gamble

Revlon

Roussel -UCLAF

Schering Corporation

Shakelee Technics

Shaperite

Sherwood Medical

Sirrine

South Research Institute

Spencer & Albright

ST & T Consultants

Starlight International

Stonybrook Labs

Synthetic Organic Chemical Manufacturers Association

Technical Assistance Bureau

Teltech

Tenzer

Texas Instuments

Texas Vet Labs

Thomas Industries

Town of Fairlee, Vermont

Tree of Life

U.S. Borax

Uniroyal Chemical

Usana

Utica Mutual Insurance

Valent U.S.A.

Veterinary Learning Systems

Warner-Lambert