International Legislative and Regulatory Advocacy Services
Acta provides the expert resources clients need to get their products to market quickly and keep them there. We help clients obtain regulatory approval and work through the legislative process. We counsel and assist clients on how to best approach officials at regulatory agencies to ensure the most accurate scientific information and policy arguments are incorporated into pending decisions. Successful and meaningful interaction with officials is particularly important in evolving spaces, such as in the EU and China, where the regulatory framework is new to regulators and market entrants alike.
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U.S.-Based Acta Initiatives and Deliverables &ndas...
- U.S.-Based Acta Initiatives and Deliverables –
- Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets
- Assist clients with developing strategies for navigating government policies and achieving and maintaining regulatory and commercial success
- Arrange and accompany clients to meetings with federal agency officials, including, most notably, EPA, USDA, and FDA
- When appropriate, arrange and accompany clients to meetings with the White House Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB)
- Inform committee staff and key state delegation members of client issues with the regulatory process and, if warranted, request letters from Congress to agency officials to help advance the process. Provide pertinent information to Congressional staff for such letters
- Guide and draft legislation and legislative initiatives pertinent to client products
- EU-Based Acta Initiatives and Deliverables –
- Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets in the EU
- Assist clients with developing strategies for navigating government policies and achieving and maintaining regulatory and commercial success
- Draft and submit comments on pending proposals by ECHA and Member States concerning specific client substances/products
- Arrange and accompany clients to meetings with the European Commission (EC), Member State authorities, and ECHA
- Asia-Based Acta Initiatives and Deliverables –
- Assist clients in navigating the cultural differences that impact regulatory developments, interactions, and interpretation
- Provide clients with timely information on and insight into key applicable regulatory developments, challenges, and opportunities to commercialize products and grow markets in Asia with emphasis in China
- Interact with key regulatory authorities to advance client product strategies; arrange and accompany clients to meetings with the regulatory authorities
Representative Engagements:
- Assist significant metals consortia in better understanding the EU regulatory process; prepare for and accompany to a meeting with the EC -- support legal team in further action.
- Assist significant U.S.-based substance consortia in better understanding the EU regulatory process; prepare for and accompany to a meeting with the EC -- support legal team in further action.
- Assist several significant multinational chemical manufacturers in understanding the regulatory framework in China, dialogue with the respective regulatory authorities to better gauge interpretation of the regulations while also offering practical solutions to complex scenarios.
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