The goal of this study is to assess the relationships between the country’s regulatory institutions and the relational capability and performance of strategic clinical trials alliances. The country’s regulation is made up of a set of formal institutions, i. e. codified rules, which aim to determine social actors’ practices. Strategic alliances are long-term cooperative relationships voluntarily established between two or more autonomous companies with shared interests and goals to create competitive advantage. Clinical-trial strategic alliances are organized according to the contractual relationship and parties’ relational capabilities that aim to overcome difficulties in the partnership activities and ensure intercompany cooperation, reflecting on organizational efficiency and effectiveness, and impacting on alliance performance.  This work developed a critical review of the literature and expanded it through the establishment of novel relational propositions regarding the relationship between formal regulatory institution of countries and strategic alliances for clinical trials of new medicines.