Our Characteristics

"There are differences in quality service. We invite you to experience premium consulting"

Best in each FDA field

FDA regulatory consulting requires very specialized knowledge in each FDA field (pharmaceuticals, medical devices, biotechnology, cosmetics, foods, animal drugs etc.). We have put together the most experienced and respected members in their respective field. Each of our consultants has 15-30 years of experience.

Located in Los Angeles, the largest port of entry for FDA regulated products

FDA has put a growing emphasis on its import operation. Los Angeles being the largest port of entry for FDA regulated products, Spherelink’s corporate location in Los Angeles will serve as a great strategic advantage over other competitors elsewhere. Los Angeles is more convenient than the east coast when communicating with Asia.

Unique knowledge of the FDA’s Import Operation

In addition to the FDA approval process, we also provide unique service for client’s FDA customs issues (detention/refusal), which is not available from most consulting firms.

Quality Assurance program

FDAlink has implemented the Multi-Screening and the Pre-FDA Critics programs to assure our service quality. The programs will help us provide you with better service. Independent consultants wouldn’t be able to do checks of their own work.

Communicating in your language

We are working to communicate with you in your own language. We are currently serving clients in Chinese, Japanese and Korean, and working to add Spanish language services soon.

Faster and more accurate professional services (international clients)

You can save up to 30-50% on project time while increasing accuracy by working with us directly. We prefer to work with you directly because brokers or middlemen will cause delays and technical misunderstanding, which can cost you millions of dollars