Kelemenis & Co. has a dedicated team working across the full spectrum of regulatory compliance, transactional matters and industry-specific litigation in the areas of healthcare and pharmaceuticals. In regulatory matters, the firm has been advising clients, domestic and international, on the full range of Greek healthcare and pharmaceutical laws and regulations relating, amongst others, to:

• Medical devices and pharmaceuticals;
• Labelling and advertising/promotional claims;
• Interactions with regulators on authorizations/approvals;
• Research (including clinical trials, post-marketing surveillance studies, partnerships);
• Interactions with healthcare institutions and healthcare professionals;
• National health systems, including pricing and reimbursement; and
• Pharmaceuticals-specific compliance (e.g. regulations on rebates and claw-backs).

Recent highlights include:

• Acting for GE Healthcare in numerous, multi-million public bids for medical equipment.
• Acting for Kleva Pharmaceuticals, a major Greek manufacturer, on rebate and claw-back matters involving the enforcement and legality of the relevant provisions.
• Advising Solvay on regulatory matters.
• Advising Stryker on regulatory compliance for its local business and on a major commercial dispute governed by Greek law.
• Acting for Devicor on the Greek end of its global acquisition of a Johnson & Johnson’s medical device line of business both on commercial and regulatory matters (e.g. regulatory compliance, filing and reporting requirements).
• Acting for Solutia on a wide range of corporate and sector-specific matters of its local subsidiary.
• Advising Premier Research on a wide variety of issues involving the undertaking of medical tests and clinical trials in Greece.

Our clients and companies rely on Kelemenis & Co team of healthcare and pharmaceutical Practice for the right expertise.