Thank you, GRP team, for registering our DMF in china. Your helped us achieve a big milestone for our company. The support and the commitment of your regulatory team have exceeded our expectations and made it easier for us to communicate with NMPA the Chinese authority. All the best !

We have been working with Global Regulatory Partners for 5 years and we consider them as our real partner and not as a consulting company, they had submitted 3 INDs for us with FDA successfully . The GRP team performs all IND amendments and annual reporting to FDA, we don’t have to worry about not being in compliance with FDA requirements at all.

After submitting our drug application to NPMA, the Chinese agency requested us to conduct a local clinical study. Finding the qualified CRO for the study management in China was very challenging process because of the language barrier and the lack of understanding of GCP and ICH requirements. We finally found Global Regulatory Partners, that has a local team of professionals in regulatory and clinical affairs in china who supported our clinical study in China, but also helped us to understand the Chinese regulations related to our product.

I am very impressed on how quickly Global Regulatory Affairs team was able to prepare and organize a face to face consultation meeting for our company with Anvisa in Brazil, The meeting was successful and helped us to validate and conform the regulatory strategy of our device registration in Brazil.