Pharmaceutical Product Development Services

Drug Development Challenges

When it comes to drug development, pharmaceutical companies face many obstacles, including:

A Lengthy, Complex Process Clouded by the Uncertainty of a Drug Succeeding

Ever-Changing Regulatory Processes

Managing and Executing Speed to Market Goals

Proper Staffing

Significant Capex Requirements

That’s why having a partner to help navigate the development process is so important. A closer look at what’s involved provides insight into the importance of having a partner to help navigate the drug development process.

What Does Drug Development Entail?

Once researchers identify a promising compound for development, they must conduct experiments before moving on to preclinical research, followed by clinical research, FDA review and finally, FDA post-market safety monitoring.

Experiments help researchers determine specific formulation information, such as:

How the Drug Is Absorbed, Distributed, Metabolized, and Excreted

Dosing Amounts and How to Administer (i.e. Oral or Injection)

Potential Benefits and Side Effects

If and How the Drug Behaves on Various Demographics (i.e. Gender, Race, Ethnicity)

Interactions With Other Drugs or Treatments

Effectiveness Compared to Similar Drugs

There are more than 181,000 clinical studies active today throughout the United States and around the globe, according to the latest information from the U.S. national institutes of health. But to put that number in perspective, consider the following:

Fewer than 1,500 drugs have been approved since the food and drug administration (FDA) came into being in 1938, according to the regulatory affairs professionals society.

Only about 5 of every 5,000 preclinical drugs will see the light of day being tested on humans. And just one of those five will be approved by the FDA, according to medicine.net.

That means nearly 7.3 million drugs were reviewed to net the 1,453 FDA-approved drugs since 1938.

Record Industry Growth

Since then, the industry has grown considerably. Just last year, more than 1,000 generic drugs were approved—a record for the FDA. Today, there are about 7,000 medications in various stages of development.

Why Collaborate With EFC Pharma?

Pharmaceutical companies have much to gain by collaborating with the right CDMO. With an extensive list of high-profile, long-term relationships, EFC Pharma empowers pharmaceutical companies to reduce business complexity, lower supply chain costs, increase market share and innovate faster.

We Are Experts In

Powering Your Most Profitable Relationships.

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.