case study

Navigating regulatory hurdles for a global life sciences company in Türkiye

CLIENT TYPE
A global life sciences company

INDUSTRY
Health & Life Sciences

LOCATION
Europe

 

Challenge

A global life sciences company faced significant barriers in bringing its products to market due to unexpected and restrictive regulations in Türkiye. These regulatory changes hindered the company’s ability to secure timely approvals and market access, threatening both the viability of its products in the region and its broader market strategy. The company needed a strategic approach to navigate the evolving regulatory landscape, advocate for favorable policies, and ensure its products could reach the market while safeguarding its business interests.

Approach
  • Developed a comprehensive strategy to navigate the new regulatory landscape, including clear messaging to articulate the company’s unique value proposition in the Turkish market.
  • Engaged key governmental and industry stakeholders to advocate for regulations and policies similar to those in the EU, aimed at fostering a more predictable and favorable environment for life sciences products.
  • Worked closely with the company to adapt to the less favorable regulatory environment, adjusting strategies where necessary to align with the new requirements.
  • Simultaneously prepared a market exit contingency plan in the event that regulatory challenges persisted, ensuring the company could mitigate losses and pivot if needed.
Impact

With our guidance, the company successfully received timely drug approvals and secured the necessary pricing to ensure the economic viability of its products in Türkiye. This allowed the company to deliver life-saving medicines to the market, benefiting both the company and the local population. Our strategic approach also positioned the company for success in other markets facing similar challenges. Over time, we provided ongoing support to address regulatory issues in other countries, including Brazil, China, Saudi Arabia, South Africa, and Venezuela, enabling the company to expand its reach and continue its mission of improving global healthcare access.