North America GeneScience is a registered United States corporation that has been providing pharmaceutical companies and compounding pharmacies throughout the world with the highest quality Recombinant Biological products available. North America Gene Science is registered with the United States Food and Drug Administration (FDA) and has been issued an NDC number (labeler code) for our facility and for each foreign produced Active Pharmaceutical Ingredient(s) that we sell.
North America Gene Science only provides Active Pharmaceutical Ingredients (APIs) and Fine Chemicals that are manufactured in factories conforming to current cGMP (Current Good Manufacturing Practices).
North America Gene Science utilizes independent outside laboratories to test all API's according to the latest editions of the USP, BP and EP. States Pharmacopia (USP) and British Pharmacopia (BP).
North America Gene Science has expertise to register your finished pharmaceutical product(s) in many countries throughout the world. We 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 your product is registered, revenue can immediately be generated.
Business activities
- North America GeneScience distributes Recombinant Active Pharmaceutical Ingredients to Compounding Pharmacies and Pharmaceutical companies.
- We can assist with contract manufacturing of specific API’s.
- We provide technical assistance and technology transfer to companies using our API.
- We have the legal expertise to register foreign manufacturing facilities and products with the United States Food and Drug Administration (FDA).
|