An in-depth understanding of the regulatory restraints imposed by Danish and European legislation is vital in ensuring that commercial strategy and agreements are going to be workable. We have that expertise.

We advise on all issues arising throughout the product life cycle. During the research phase, we advise on legal and ethical issues in clinical trials in relation to subjects, investigators, study sites and ethics committees. Pre-marketing, our assistance is commonly sought in testing or challenging a position taken by the applicant or competent authority. Post-marketing issues we are asked to advise on include labelling, advertising, vigilance and supply. In addition, pricing and reimbursement issues are playing an ever increasing role in getting products to market.

We advise on all aspects of the regulation of pharmaceuticals and medical devices, including the following areas:

• Clinical trials
• Marketing authorisation
• Promotional activities
• Unlicensed products
• Medical devices
• Borderline products (drug/device)
• Pharmacovigilance and device vigilance
• Data protection
• Pricing and reimbursement
• Packaging, labelling and inserts
• Good manufacturing practice (GMP) / Good clinical practice (GCP)
• Product liability