Overcoming regulatory challenges with local expertise

Navigating the complex landscape of EU regulatory standards can be challenging, and pharmaceutical companies need thorough understanding of the guidelines, along with flexibility and agility to adapt to evolving regulations. The Bourgoin site leverages European expertise to streamline the regulatory process, reducing delays and accelerating market entry. The experts at Bourgoin are fully versed with EU regulations and can provide access to certified Qualified Persons (QPs) who oversee the release of products for the European market. These QPs ensure that all products meet stringent regulatory requirements, maintaining the highest standards of quality and safety. This local expertise is invaluable in bringing high-quality pharmaceutical products to the European market faster.

Enhanced supply chain stability through localized production

Ensuring timely delivery managing budgets are critical challenges for pharmaceutical companies looking to expand their footprint in Europe. By reducing reliance on long global logistics chains, companies can minimize the risk of supply chain disruptions. Leveraging a partnership with a strategically located production facility, like the Bourgoin site, can enhance supply chain stability. Proximity to key European markets not only ensures timely delivery but also reduces transportation costs, customs fees, and lead times, helping companies manage budgets more effectively.

Adapting to market demands with specialized production capabilities

Meeting fluctuating market demands and adapting to evolving needs are significant challenges for pharmaceutical companies. With the ability to easily scale up or scale down production, adjust formulations, and adapt to market changes, companies can stay competitive. Partnering with a facility like the Bourgoin site, which is equipped with specialized expertise and advanced technologies in high-potent active pharmaceutical ingredient (API) and oral dosage forms (OSD) formulations, can make a large impact. This allows the facility to adapt production processes and scale operations to meet the increasingly complex demands of the evolving European market. Additionally, Thermo Fisher fosters lasting relationships with clients and invests in local talent and technology to support clients’ goals in Europe.

Conclusions:

Navigating regulatory and logistical challenges is crucial for pharmaceutical companies aiming to succeed in the European market. Having a local production facility with expertise in regional regulatory affairs in a strategic location can significantly stabilize supply chain logistics. Thermo Fisher’s Bourgoin site exemplifies these benefits and offers comprehensive services that can be tailored to companies of any scale and at any step of drug development. This support enables pharmaceutical companies to effectively expand their presence in the European market.