FDA Approval: Drugs

The U.S. FDA regulates drugs products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of humans or animals. TechLink International provides Registration, U.S. agent, and compliance assistance for U.S. and non-U.S. companies in the drug industry.

Our goal is to provide you with courteous, expedient, pragmatic and professional advice of the highest level – whether it is a small assignment or a comprehensive compliance solution.

With global strategic expertise that extends from the U.S. to South American, Mexican and Canadian markets, our consultants provide the best solutions for both established and novel pharmaceutical dosage firms across a wide range of therapeutic areas.

Overview of the FDA / Drugs

The center that is responsible for ensuring that prescription, over-the-counter, and generic drugs are safe and effective and work correctly is the FDA CDER (Center for Drug Evaluation and Research).  The CDER regulates a wide range of products, including fluoride toothpaste, aspirin, sunscreens and cancer treatments. They oversee new drug development, manufacturing, approval, post-market performance, drug labeling and drug promotional information. The CDER analyzes the data that drug manufacturers submit to them to determine if the drug works according to its intended use. If the CDER determines that the drug is safe and effective, they will approve the drug. The CDER also has the authority to take action if unexpected risks occur after a drug has been approved. These actions include informing the public, having the label changed, or removing the product from the market.

We can assist you with the following PRESCRIPTION (RX) / OTCs / HOMEOPATHIC drug requirements:

• FDA Establishment Registration
• Drug Listings and Label Submissions
• U.S. Agent Requirement
• Authorizing Official Requirement
• Medical – Pharmaceutical translations

Label / Ingredient Reviews and Graphic Design

The TechLink International staff of translators and graphic designers have adapted hundreds of PRESCRIPTION DRUG (RX) labels.  You provide the original information, and will receive from us an FDA-complaint version of your label, ready to be printed.

Let TechLink International consulting team put you on the path to compliance and open the door to new sales opportunities in the United States.

Call us for more information.