Are you planning to register and market your pharmaceutical, medical device or food and dietary supplement in the US?
Do you have a US agent?
All non-U.S. Food, Beverage, Dietary Supplement, Medical Device or Drug companies who wish to market products in the USA must have a designated US Agent. The role involves managing all communications with the FDA, coordinating regulatory submissions, drug establishment registration and updates, product listings, compliance and facilitating inspections.
Why work with us?
Kinapse, part of Syneos Health® (a US NASDAQ listed company) has a team of expert US agents based in the US supported by our expert team in India, Europe and US. This offers ‘round the clock support’ for our clients and a wealth of knowledge to ensure successful delivery.
At Kinapse we provide:
- FDA correspondence and regulatory responsibilities undertaken professionally and confidentially.
- Competitive and consolidated pricing.
- Focused delivery as per individual client requirements.
- Excellent regulatory awareness and end-to-end expertise including clinical product development and commercial aspects.
- Support for future business plans for growth.
- Assurance of successful lifecycle maintenance and monitoring of regulatory compliance of marketed products.