We have extensive experience advising life science companies and companies in other heavily regulated industries covering a broad range of issues that arise throughout the life cycle of the product.
We combine our life science regulatory expertise with our practice on compliance and enforcement matters to assist companies in conducting internal investigations and implementing compliance programmes including risk assessment, remediation plans, enhancement of policies and training.
Expertise
Our advice is based on many years of practical experience in the life science industry and other heavily regulated industries.
Regulatory
- Research and Development
- Contacts with relevant authorities
- Market access including price and reimbursement, three-party negotiations and “side agreements” between manufacturers and Regions
- Regulatory Data Protection
- End of exclusivity matters including substitution
- Off Label Use
- Advertisement
- Marketing v. Freedom of Speech
- Cross border health care
- Litigation before administrative courts and industry bodies
Risk Management & Compliance
- Internal investigations
- Risk assessments
- Compliance programmes, SOPs etc
- Training, documentation and monitoring