Case Study 50 : Pre-NDA meeting with FDA for 505(b)(2)
US based manufacturer of pharmaceutical products needed to understand the possibility of submitting NDA to US FDA using the 505 (b) 2 pathway.
Case Study 42: Registration of Class II Medical Device in USA via 510(K)
EU-based manufacturer of Class II medical devices with a CE mark seeks GRP as partner in USA to support the registration process US FDA via 510(k) pathway.
Case Study 43: Using foreign Clinical Data for the Submission of IND in USA
Taiwan based biotech company wishes to continue IND clinical study phase 2 of study in USA by using Phase 1 data in Taiwan. Client seeks GRP as US agent.
Case Study 45: GMP Mock Audit for China NPMA Pre-approval Inspection
A large US-based pharmaceutical company that was in a process of registering one of its new drugs in China requests GRP to conduct for a GMP Mock-up.
Case Study 49: Regulatory Support for Cosmetic Notification in the EU
US based Tele-Densitry client seeking partner for global access and regulatory strategy for getting registration of cosmetic product in EU.
Case Study 41: Regulatory support for QMS Set Up for US-FDA.
Medical Device compnay requests assistance to write applicable SOPs, quality manual and to also provide training for QMS set up with FDA standards