The Acta Group (Acta) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, products of biotechnology, nanotechnology, and medical devices. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach. Acta partners with our clients to help them get products quickly and efficiently to market -- in any country or locale -- and keep them there when challenged by a new regulatory regime, issue, or set of rules. Consultants manage products from concept to approval, delivering skills and experience with specific product areas in government and industry. We keep our clients informed about legislative, administrative, and scientific initiatives and how they will affect their businesses.
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- Business Type:
- Consulting firm
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- Market Focus:
- Internationally (various countries)
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This company also provides solutions for other industrial applications.
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Acta professionals are scientists and business and regulatory consultants. This combination -- and our wealth of experience in and out of laboratories as well as government agencies -- makes Acta an exceptional resource for companies in the chemical space. The group maintains offices in the U.S., Europe, and China, and offers expertise with regulatory programs and chemical product approvals in North America, the European Union, South and Central America, Asia, and the Pacific Rim.
Acta is a consulting firm 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 manages 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 represents 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 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 Acta professionals cover a wide range of chemicals and products, including:
- Synthetic chemicals
- Antimicrobials and wood treatments
- Biopesticides, including microbial based and plant extracts
- Growth regulators
- 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
Products of Nanotechnology and Biotechnology
Acta concentrates 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 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.