| Company Background |
Keller and Heckman LLP, founded in 1962, has a broad practice in the
areas of regulatory law, litigation, and business transactions, serving both
domestic and international clients. Our firm is a pioneer in the use of
interdisciplinary approaches to problem-solving. Since 1971, we have
had in-house scientific staff that work closely with the firm's attorneys on
matters of technical complexity. Many of our attorneys also have
government experience and expertise in multiple areas of the law.
Keller and Heckman represents a wide spectrum of companies and trade
associations servicing a range of industries, including food and food
additives, plastics, pesticides, industrial and specialty chemicals, drugs
and medical devices, transportation, and telecommunications. The firm's
practice covers the diverse regulatory areas that affect these industries,
as well as business counseling and litigation issues. Our attorneys and
scientists emphasize creative service to clients involved in the
development of new products, services, and markets. |
| Work Area Details |
- Consortium management
- Dossier preparation & data management
- Legal services
- With its combination of legal and scientific expertise and thorough
command of both legal and scientific aspects of REACH, Keller and
Heckman LLP offers creative legal solutions to complex regulatory
situations, including consortium agreements; supply chain contracts and
contracts; data sharing disputes; restriction of access to consortia, and
any other legal issues resulting from the interpretation or the
implementation of the Regulation. We may also assist in remedying
consequences of REACH before the Agency, the European Commission
and Courts.
- Pre-registration/Registration
- Keller and Heckman LLP offers representation services for registration
in the substance information exchange forum (SIEF). Such services range
from pre-registration and registration submissions to Consortium set up
and management, technical consulting to consortia, third party for
handling of CBI-sensitive information, Dossier compilation, preparation
of robust study summaries, preparation of CSRs, SDSs, exposure
assessment/modeling/scenarios, chemical characterization, follow-up of
evaluation with the Rapporteur Member State and the Agency.
- Risk assessment (environmental)
- Risk assessment (human)
- SIEF facilitation
- Testing strategies
Keller and Heckman experts strongly believe that strategic advance
planning ensures that the work is focused on meeting the REACH
obligations in the most cost effective manner with the minimum amount of
expensive testing and effort expended on dossier development. Keller
and Heckman experts will thoroughly assess the existing data and
develop a testing strategy that fully advantages opportunities for category
development, read-across, QSAR analysis, and exposure- and
substance-specific based endpoint waivers. When new tests are needed,
our scientists have direct experience running laboratories and will place
and monitor studies at the best lab, or provide expert review for studies
already conducted - Third party representative
- Corporate strategy/advice
REACH requires a great deal of work to comply in a relatively short
timeframe and even after pre-registration, companies must understand its
complexity; adopt the relevant strategy and action plan; prepare
communications in the supply chain; prepare its participation in consortia;
and select adequate resources.
With its combination of legal and scientific expertise, Keller and
Heckman LLP offers full REACH services: scope issues, prepare and
file registration dossiers, negotiate data sharing, consortia management,
argue data waivers and evaluations, file authorization dossiers, etc. while
protecting confidential business information. - Supply chain communication
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