For pharmaceutical companies distributing products in the United States, partnering with a domestic FDA-approved facility is the logical choice to maximize market opportunity. Time and time again, overseas manufacturing has shown to increase the odds of compliance issues, interrupted production, and delivery delays. Partnering with a capable stateside CMO or CDMO eliminates many of these potential obstacles.
A pharmaceutical manufacturer’s compliance with FDA regulations is a primary consideration when discussing any domestically distributed product. Moreover, maintaining a positive record throughout the course of a facility’s life will impact the speed at which a product can be brought to market.
EFC Pharma’s domestic manufacturing partners hold themselves to the highest standards to ensure uninterrupted development, testing, and production. Our network of CMO and CDMOs not only possess a clear history of compliance, but one of operating above reproach. Going beyond what is needed to maintain FDA approval means we can offer state-of-the-art facilities that surpass expectations.
Compliance with international regulatory bodies such as Health Canada and the European Medicines Agency affects companies operating on a global scale. One example is the decentralization of the EMA. Whereas the process of gaining FDA approval and compliance is centralized by design, the EMA presents many new considerations for those who wish to manufacture overseas.
Health Canada’s unique approval process and compliance guidelines are yet another hurdle those manufacturing outside the United States must overcome. Though similar in many ways to the expectations of the FDA, Health Canada’s testing and approval requirements are notably stringent and time consuming, particularly for new products.
EFC Pharma proudly serves the pharmaceutical industry as the leading development, production, site transfer, and compliance specialists. Our relationships throughout the U.S and international markets allow us to facilitate the most profitable solution for your manufacturing and development obstacles. For further information about our production and development services, please contact us here.
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