CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

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Services Offered

The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) offer a complete line of services intended to take a product or product concept to the point of its commercial marketing, to protect the market position of new and existing products, and to maintain products once they have been approved.  Among these services are:

n       Preparation of the strategy and project plan for product development, approval, and market introduction;

n       An assessment of relative product safety issues and analysis of regulatory, product liability, and/or political challenges likely to be encountered in gaining regulatory acceptance of the product and a strategy for overcoming regulatory, introduction, and/or marketing barriers;

n       Development of a dossier for the scientific data required for product approvals;

n       Estimates of costs and timelines for the approval process based on the principles of total project management;

n       Planning for and integrating essential elements of product stewardship into product development;

n       Identification of global expansion markets;

n       Legal assessment of areas of potential liability arising from regulatory scrutiny, activist attention, product tort liability, and assertions by competitors;

n       Government affairs assessment of political challenges likely to influence product approvability and/or marketability;

n       Assessment of available data to support product registration or approval;

n       Monitoring legislative and regulatory developments at the international, national, and state levels;

n       Development of strategies for intermediate approvals, including Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Experimental Use Permits (EUP) and Section 18 Emergency Exemptions, and Toxic Substances Control Act (TSCA) Premanufacture Notification (PMN) and Microbial Commercial Activity Notice (MCAN) challenges; and

n       Training services for client staff to enhance skills necessary to succeed in global regulatory affairs.

Additionally, Acta and Acta EU offer a complete line of hazard communication and label preparation services.  These include:

n       MSDS Preparation

Creation of Safety Data Sheet (SDS, or MSDS in the United States) for pure chemicals or mixtures.  This can be done for a variety of standards and regions including:

Ø       ANSI

Ø       ISO

Ø       EU Directives

Ø       OSHA

Ø       WHMIS

Ø       Individual countries in Asia, Europe, and Latin America

n       Label Statement Preparation

Creation of label text statements for industrial and consumer labeling requirements in a variety of regions including:

Ø       OSHA Industrial

Ø       CPSC Consumer

Ø       WHMIS Industrial

Ø       Canadian Consumer

n       MSDS and Label Statement Maintenance

Regulations in every region of the world state that MSDS and Label Statements must be maintained with current and accurate information.  Acta and Acta EU can archive and update any of these documents at an agreed-upon interval.

n       Hazard Evaluations and Product Ratings

Products can be rated for potential hazards along a variety of standards.  These can include toxicological (human) effects or physical-chemical properties such as flammability and corrosivity.  Acta and Acta EU can follow existing standards such as HMIS (II or III), WHMIS, and NFPA or we can follow criteria which are set up specifically by a company.

n       Transportation Classifications

Acta and Acta EU can provide the proper classification or the proper shipping description for material being transported by any UN Recommendations-based transportation regulation.  These include:

Ø       DOT

Ø       TDG

Ø       IATA

Ø       IMO

Ø       ICAO

Ø       RID

Ø       ADR

These services, whether all or selected subsets of them, are intended to be of the most use to companies intending to launch new chemicals and/or biotechnology and nanotechnology products; companies considering whether to acquire existing chemicals and/or chemical companies in transactional settings; companies examining the business sense of satisfying FIFRA Data Call-Ins (DCI), TSCA PMN requirements, or of defending their products against other regulatory challenges; and companies managing global chemical product testing requirements arising under EPA’s and the Organization for Economic Cooperation and Development’s (OECD) High Production Volume (HPV) Testing Initiatives, EPA’s Children’s Testing Initiative, EPA’s and the European Union’s Endocrine Testing Initiatives, EPA’s Persistent, Bioaccumulative, and Toxic (PBT) Testing Initiative, and related domestic and international product testing programs.

Acta and Acta EU work equally well when given total project management directives or when asked to supplement in-house capability with targeted project support services.  Either way, clients can expect service at the highest standards of professional excellence.

Acta and Acta EU appreciate this opportunity to provide information about its services, and the professionals who provide them.  Additional information can be obtained by calling us at (202) 266-5020.