The Acta Group

The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) are consulting firms established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market chemicals, products of nanotechnology and biotechnology, and medical device products. Acta and Acta EU manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry. Acta and Acta EU represent the following disciplines:

• Regulatory Affairs: Professionals skilled in the requirements for approval, including the content and form of submissions, and experienced in overall project management.
  
  
• Toxicology: Professionals skilled in conducting literature searches, technical reviews, in-depth data reviews, study design and management, risk assessments, and exposure assessments for products regulated by the United States Environmental Protection Agency (EPA), United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA).
  
  
• Government Affairs: Experts skilled in the workings of the regulatory agencies and adept at involving the executive and legislative branches of government, when necessary, to resolve policy issues.

Acta and Acta EU professionals have experience in regulations affecting chemical product approvals under North American (USA, Canada, and Mexico), European Union, South American, Asian, and Pacific Rim regulatory programs.  They regularly track significant legislative, administrative, and scientific initiatives that relate to the business of clients marketing chemicals and medical products for multiple uses.

The experience and expertise of The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) professionals cover a wide range of chemicals and products, including:

Pesticides

• Synthetic chemicals
• Antimicrobials and wood treatments 
• Biopesticides, including microbial based and plant extracts
• Growth regulators
• Repellants
• Plant protectives, including biologically or biotechnologically enhanced crops and other products of biotechnology

Industrial Chemicals and Specialty Chemicals Regulated under the Toxic Substances Control Act (TSCA)

EPA/FDA Regulated Products

• Direct and indirect food contact products
• Antimicrobial products

Medical Devices

Products of Nanotechnology and Biotechnology

Acta and Acta EU concentrate on obtaining and maintaining product approvals and overcoming impediments to the successful and profitable marketing of approved products. The multi-disciplinary skills possessed by members of Acta and Acta EU are essential to a cost-effective and timely product approval project. Today’s regulatory approvals hinge on the utilization of multiple sources of information, resources, and skills. The elements of such a program include:

• A detailed understanding of the applicable regulatory requirements and governing laws for the product(s) when used as intended;
• Analysis of regulatory and political circumstances that could influence the approval process;
• Information regarding approvals of the substance, entity, or product for other uses and in other global markets;
• A preliminary market needs/benefits analysis;
• Information on structurally similar products or products of a similar nature;
• Intelligence on select existing competitive products already on the market and those likely to come on line imminently;
• Formulation plans;
• Product study results; and
• A preliminary global marketing plan setting forth the client's objectives.

The Acta Group, L.L.C. has entered into an exclusive collaborative partnership with Life Plus LLC to provide expertise on Asia's biotechnology-related product registration process. More information.