Case Study 047: Waiver of FDA Fee for NDA in USA
A European mid–size pharmaceutical company that developed a new drug for the treatment of prostate cancer. The client wanted to register the NDA of the new drug with US FDA.
Case Study 006: RA Strategy for Drug Market Exclusivity in USA
European Pharma Company that sells a drug for a rare disease was looking for RA experts to find new ways to extend their products in USA.
Case Study 163: Orphan Drug Designation (ODD) in USA for Castleman Disease
Client is a UK Based pharmaceutical with Orphan Drug developed for Castleman Disease, GRP has FDA- consulted our client for over 5 years
Case Study 106: Spa Cosmetic Products Registration in the USA
Client was looking to sell their beauty products in USA. They wanted us to provide information concerning registration and selling of cosmetic products in the country.
Case Study 66: Investigational Device Exemption (IDE) in USA
The Client is a Chinese based invitro diagnostic kits manufacturer seeking a partner to support with preparation and submission of investigational device exemption (IDE) application to FDA.
Case Study 157: IND Submission to US FDA for a New Chemical Entity for the Treatment of Gout
The client has developed a new drug, class 1 new chemical drug as per classification in China and was planning to submit the IND in China.