Life Science: Biotech, Pharmaceutical and Medical Devices Law

VOELKER's Life Science Team is specialized advising regulatory affairs for pharmaceutical products as well as for medical devices. We draft and negotiate agreements for research and development partnerships, research consortium agreements and contracts for manufacturing of pre-clinical and clinical material.

The areas of service of the Life Science Team provides services in the following areas:

• Regulatory Affairs for Pharmaceutical Products
• Regulatory Affairs for Medical Devices
• Pharmaceutical Product Registration at BfArM and EMEA
• Medical Devices Registration
• Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
• Biotech Agreement
• Research and Development Agreements
• Research and Development Partnership
• Contract Research Agreements (CRO)
• Contract Manufacturing Agreements (CMO)
• Clinical Trial Agreements
• Grant Agreements
• Development Consortium Agreements
• Licensing Agreements
• Agreements with Notified Bodies
• Quality Assurance Agreements
• OEM/PLM Agreements
• Duties and Liabilities of Qualified Persons
• Medical Devices Law (Medizinproduktegesetz, Medizinproduktesicherheitsverordnung; European Medical Devices Regulation)
• Pharmaceutical Law (Arzneimittelgesetz)
• Warranty, Liability and Indemnity
• Jurisdiction Clauses
• Arbitration Clauses
• Conflict of Laws, International Private Law and Choice of Law

If disputes arise on research, development or licensing agreements, we are can assist in:

• Litigation
• Arbitration ICC, DIS, AAA, CIETAC, Swiss Rules, Stockholm Chamber of Commerce SCC
• Jurisdiction Clauses

Once a pharmaceutical product or medical device is supplied to a customer, we advise on product-related risks:

• Product Liability
• Product recalls
• Product Liability Insurance
• Product liability of directors and officers
• Incidents and accidents
• Pharmavigilance, Pharmakovigilanz