Maria-Oraiozili Koutsoupia, Ph.D.
Maria-Oraiozili Koutsoupia counsels clients on regulatory and compliance matters related to pharmaceuticals, medical devices, AI, data protection, food packaging, and drug packaging.
On the data side, Maria-Oraiozili assists clients in understanding complex matters and advises them on developments due to advancing technologies and increased regulations. She has extensive knowledge on the regulatory and legislative requirements related to healthcare law, data processing, and cybersecurity in the European Union but also in other jurisdictions, and helps clients find solutions irrespective of where they are located.
In her food packaging practice, Maria-Oraiozili advises companies in obtaining regulatory clearances for food-contact materials and packaging in EU Member States and drafts opinion letters regarding these clearances.
Prior to joining Keller and Heckman, Maria-Oraiozili served as a life sciences attorney for a leading law firm in Greece where she advised pharmaceutical companies on complex regulatory issues and supported them in public tenders as well. She holds three LL.M. degrees along with a doctorate in public administrative law, which serve her well in understanding the complexities of EU and international regulations and in handling the interactions with the authorities.
- Advised clients on labelling issues, CE marking, and various regulatory requirements for medicines (either for human use or veterinary), medical devices, food for special medical purposes, infant formulae and follow-on formulae, food supplements, personal care products and cosmetics, biocides, and pesticides
- Advised clients on the implementation of data privacy and security policies
- Drafted regulatory letters of opinion on the status of food-contact materials on behalf of companies
- Provided legal support regarding medical products’ authorization procedures, excipients supply, orphan drugs distribution, and medical devices classification
- Drafted standard operating practices (SOPs) for regulatory matters including pharmacovigilance, interactions with healthcare providers, anti-corruption, transparency, advertising, and best promotional market practices
- Advised on the conduct of market research activities and preparation of the relevant agreements and questionnaires/surveys
- Represented clients for advertising, labelling, clawback, and rebate cases before the Administrative Courts of Athens