Life Sciences & Biotech
Hall Render attorneys have experience advising clients in various areas of pharmaceutical, medical device, biotechnology and life sciences research law. We have handled a broad spectrum of matters for our clients, 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 life sciences industry allows us to provide prompt, effective counsel to our clients. We have also assisted clients with related areas, such as advertising medical products and pharmaceutical trade.
Areas of Law
- Clinical Research
- Creation, organization and improvement of research programs
- Preserving integrity in research
- Good clinical practice methods
- Clinical Trial Agreements
- Institutional Review Board issues
- Intellectual Property and Technology
- Data transfer and privacy issues
- Intellectual property and technology transfer
- Licensing
- Compliance
- Pharmaceuticals and Medical Devices
- 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
- Administrative Matters
- Facilitation of effective communications with agencies, authorities and legislative bodies
- Advice on health care products advertising
- Counsel regarding pricing issues
- Assistance with regulatory inspections and corrective action responses
- Governmental Regulation
- False Claims Act counsel
- Food and Drug Administration regulations
- The Common Rule
- Research Misconduct Investigations
- 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 Privacy Directives
© 2013. Hall, Render, Killian, Heath & Lyman, P.C.
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