Registration Consultancy

Regulatory Services in United States of America

The American pharmaceutical industry is a highly globalized industry. The industry alone holds almost half of the global pharmaceutical market, with sales of drugs in the country making up 48% of the global market for pharmaceuticals as of 2019.

The GDP per capita in the United States is was estimated to be 65,116, U.S. dollars in 2019. The pharmaceutical market in the United States is on a solid incline. It is projected that by 2023, Americans would spend between $635 and $655 billion on medicine. This represents a solid 29.6 – 33.7% increase in expenditure compared to 2019. This will undoubtedly make it the country with the highest pharmaceutical expenditures.

Regulatory Authority

United States Food and Drug Administration

Market Size

Touched US $490 billion in 2019, and growing.

Regulates

Drugs, OTC, Medical Devices, Cosmetics, Food

Local Industry

Meets a small part of the complete food and pharmaceutical industry requirements

Why partner with Genedrift

"Time isn't the main thing, It is the only thing"

- From start to end, we offer it all, in addition to ensuring the safety and security of your registrations.
- With no commercial interest in products, we hand the registrations to you as soon as received and ensure un-hindered business from your registrations
- Communicate with us in English, Hindi, Vietnamese, Burmese, Russian, whatever is comfortable with you. Our team is spread across various geographies, offering excellent communication

Speed & Accuracy

We ensure that your application are correctly filled, and they move through the right departments and procedures in the FDA.

Safety of Data

Preventing any data leaks and unwanted access to your data, we carefully control access of each employee to customer data.

Pre-Review

All applications and dossiers are reviewed internally before being forwarded to FDA saving applicant time and money, both.

Start to End

Providing a customized solution, from the very start to the last stage, all activities can be outsourced, and you can focus on other activities at hand.

Local Entity

Genedrift is a local corporate entity permitting to apply and act as local legal agent for your submissions. Working with full time staff, to cater to all regulatory needs.

FDA Agent

We act as your FDA Agents, responding to any questions FDA may have regarding your listing / registrations.