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Testing Coordination to Support Global Registration

Overview:

To market a chemical-based product successfully, a company must work through many strategic steps, from product development, to testing and compliance, to market placement. As part of this process, the company must determine the optimal size and breadth of a product’s market. For instance, a company must determine if the cost of regulatory approval to gain market access in a particular country is exceeded by the demand for the product in that market. The company must also undertake product testing, which varies per product as well as per market. To achieve long-term success, companies can benefit immeasurably from careful planning that factors technical, regulatory, and commercial variables.

The Acta Group (Acta®) is comprised of professionals with the technical and regulatory know-how, the commercial sense, and the strategic resources to help companies in the chemical space at all these stages. Our consultants can guide your company in the strategic planning process to determine the right markets and can help you navigate the regulatory schemes of those markets. To simplify the process, with our global presence and strategic partnerships, Acta has access to the right testing facilities no matter where you decide to take your product. 

Our Experience:

Acta professionals are scientists and business and regulatory consultants. This combination -- and their wealth of experience in and out of laboratories as well as government agencies -- makes Acta an exceptional resource for companies in the chemical space. Our global presence, with offices in North America, Europe, and Asia, and strategic partnerships throughout, makes Acta an invaluable resource for companies who operate across countries.

Andrew Burgess brings to Acta his extensive knowledge of international chemical control legislation and regulatory affairs. While Mr. Burgess’ experience extends from China to Europe, he currently concentrates on matters through Acta’s practice in China. Mr. Burgess has been deeply engaged in China chemical registration and support activities for the last six years and has gained unique insights and knowledge of the legislation and its practical implications for businesses.

Emma Louise Jackson, CBiol MSB, is distinguished by more than a decade of experience in testing and regulatory environments. She develops testing strategies for worldwide regulatory schemes, including data review, data gap analysis, testing proposals, read-across, data waivers, and preparing predictions. Ms. Jackson also provides advice on testing requirements for classification and labeling of substances, mixtures, and products using alternative and in vitro test methods where appropriate.

Yang Ni, based in China, serves as clients’ on-the-ground guide to expanding their markets to China. His office provides research and development testing as well as regulatory support to multinational industrial chemical conglomerates. For these companies, Mr. Ni’s knowledge of Chinese regulations, and his longstanding relationships with the appropriate contacts, is instrumental to his clients’ success.

United States-based organic chemists Drs. David Peveler and Joseph Plamondon have spent decades consulting with chemical companies on a broad range of chemical regulatory issues and have written extensively on such matters.

Dr. Jane Vergnes, DABT®, based in the United States, is a highly-skilled research scientist and toxicologist with a Ph.D. in human genetics and 25 years of experience that includes corporate leadership in product stewardship for international chemical companies. Dr. Vergnes assists clients in pinpointing which toxicology issues must be addressed, designing cost-effective testing strategies, and evaluating external testing providers. Her unparalleled understanding of the science, business, and policy issues facing clients is a powerful asset to our international clients.

Also in the U.S., Dr. Brian Xu, DABT®, is a board-certified toxicologist with an M.D. in pathology and a Ph.D. in pharmacology and toxicology. Dr. Xu designs safety testing, risk assessment, product safety, and regulatory compliance programs, works with clients to place, manage, and monitor toxicological and clinical tests, and ensures Good Laboratory Practices (GLP) at laboratories in the U.S. and China. Fluent in English and Madarin, Dr. Xu assists clients in the preparation of dossiers in English or Chinese.

Lara Hall, M.S., a scientist and Registered Quality Assurance Professional in Good Laboratory Practice (RQAP GLP), has over a decade of experience in monitoring and auditing studies through all phases of environmental testing programs, including test plan development, laboratory inspection and study placement, protocol development, dose selection, in life monitoring, and report and data review for scientific integrity and compliance, budget management, and sponsor updates.

What We Do:

Acta professionals have the technical and commercial know-how to help design, implement, and complete a cost-effective testing program.

  • Country-Specific Compliance Testing and Certification –
    • Assist in the approval and regulation of chemical products
    • Assist with reporting obligations for new and existing chemicals
    • Assist with labeling and notice requirements
  • Facilitate Product-Specific Testing, including
    • Product safety
    • Product design
    • Industry performance

Representative Engagements:

  • Assist multinational company in developing a testing strategy to comply with various countries’ new chemical substance requirements.
  • Assist multinational company in addressing testing strategy due to substance identification modifications (no longer existing substance).
  • Assist multinational company in addressing and conducting testing to meet REACH requirements.
  • Assist multinational company in testing strategy in association with the U.S. High Production Volume (HPV) Program and Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) (now COCAM) Program.

 
THE ACTA GROUP
Beijing, China | Manchester, U.K. | Washington, D.C.
 
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