Registration and Sales in the United States

North America Gene Science has the expertise to register your foreign manufacturing facility and each Active Pharmaceutical Ingredient (API) and or Raw Material you wish to import and sell in the United States with the United States Food and Drug Administration (FDA).  North America Gene Science will confidentially act as your required United States agent.  We will file all updates and amendments with the FDA as required, ensuring your company is continuously compliant with complicated US and US FDA laws and regulations.  North America Gene Science will manage our strategic partners to market and distribute your products in the United States.

Registration and Sales in Other Countries

North America Gene Science can assist foreign pharmaceutical companies with marketing & selling their finished drug products, Active Pharmaceutical Ingredients and Raw Material in many regions throughout the world.  We have the technical and legal expertise to perform an in depth review of your company’s product(s) and then develop the most viable business model specific to each company, product and country. 

Registrations and licensing will vary for each country; this includes the technical requirements, cost and length of time it will take to complete the registration. 

North America Gene Science will contract with your company and handle all the regulatory and compliance affairs until your product is officially licensed and registered within the desired country.  While your product(s) and company are being registered we will form strategic distribution, marketing, and sales channels so that once registration/licensing is complete, revenue can immediately be generated.