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Life Sciences
Hall Render attorneys have experience advising clients in various areas of pharmaceutical and medical device law including regulatory compliance, governmental investigations and defense, conducting clinical trials, product liability defense, intellectual property, labor and employment, and business transactions. Our experience in the many areas of law impacting the industry allows us to provide prompt, effective counsel to our clients. We have also helped clients with related areas, such as advertising medical products and pharmaceutical trade, as well as general matters of health care law, from HIPAA to medical practitioners' law.
Areas of Focus
- Creation, organization and improvement of research programs
- Preserving integrity in research
- Good clinical practice methods
- Data transfer and privacy issues
- Intellectual property and technology transfer
- Compliance
- Legal monitoring of the development of new pharmaceutical products and medical devices
- Advice on trade/sale of pharmaceutical products
- Advice regarding intellectual property and technology transfer issues for pharmaceutical products and medical devices
- Advice on the marketing and distribution of pharmaceutical products
- Facilitation of effective communications with ministries and legislative bodies
- Advice on health care products advertising
- Representation of authorities, associations, and international organizations
- Counsel regarding pricing issues
- Provisional counsel to ministries and legislative bodies
- False Claims Act counsel
- Food and Drug Administration regulations
- The Common Rule
- Federal and state anti-kickback and fraud and abuse laws
- Federal and state self-referral laws, including the federal Stark law
- Federal, state and international privacy laws, including HIPAA and the EU Directives
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