Gemma Colomer specializes in providing comprehensive advice to national and international companies on regulatory law in the pharmaceutical and healthcare technology industry. She assists companies throughout the entire product lifecycle, from research and development, to market access and commercialization.
Her expertise covers regulatory affairs in the pharmaceutical and healthcare sector and the pharmaceutical and medical devices market, and she handles contract negotiation in the sector (clinical trials and investigations, license and supply agreements, co-development and manufacturing). She is also an expert in the industry’s sectoral codes (Farmaindustria, MedTech, and Fenin) and is a specialist in developing and implementing sectoral compliance programs and revising and validating promotional actions and patient support programs.
Her experience enables her to advise on regulatory disputes and litigation proceedings in court and before the competent authorities.
Gemma teaches in leading master programs, including the Master in the Pharmaceutical and Biotechnology Industry at Universitat Pompeu Fabra (Barcelona) and the Course in Pharmaceutical Law at the Barcelona Bar Association. She also regularly contributes to industry publications.