Life Sciences

Mixing poison and making a “medicine” out of it via the trial-and-error method certainly belongs to the past. Today, the path from the invention to the marketing of a medicinal product or medical device is strictly regulated. We will be of assistance when walking on this not straight road and help you to interpret the road signs correctly.

  • Borderline: medicinal product-medical device-cosmetic-food;
  • Regulatory consulting in pharmaceutical law and medical device law (Medicines Act (human and veterinary) and Medical Devices Act 2021) as well as in the area of the Medical Devices and In Vitro Diagnostics Regulations and their national implementation;
  • Legal support for drafting clinical trials (CTRA), NIS and post-marketing surveillance studies (PMS) plus anti-bribery advice;
  • Assistance with trade registrations under the applicable laws (Trade Act), e.g. wholesale trade permist for pharmaceuticals / medical devices, appointment of managing directors under the Trade Act, obtaining operating facility permits;
  • Obtaining and maintaining GMP/GCP certificates plus representation before the competent authority;
  • License agreements: Early development to distribution of approved medicinal productsor CE-certified medical devices/IVDs (distribution contracts);
  • Production contracts (special focus on GMP)/contract manufacturing contracts;
  • Reimbursement of medicinal products (Reimbursement Codex) and for medical devices;
  • In-house training on advertising law and competition law issues;
  • Support during inspections by national and by the EU Commission (“dawn raids”);
  • Antitrust advice, in particular on R&D contracts and on horizontal and vertical agreements at all trade levels.

Foto: CC0 – Unbekannt – Wien Museum 58129/53