Regulatory & Medical Implementation

What We Do

Elite provide regulatory and medical consulting and implementation services for venture backed companies and mid-sized multinationals. With thorough understanding of the regulatory process and has strong ties to healthcare institutions and governmental agencies, Elite offers a range of services, including CFDA registration, KOL mapping for clinical trial, KOL recruitment and engagement management,CFDA clinical trial protocol development, and clinical trial management.

Our Strengths

Understanding of the regulatory process

  • Extensive experience with CFDA and CMDE registering innovative medical devices
  • Dedicated personnel keeping up to date with newest regulations

Strong ties to healthcare institutions and governmental agencies

  • Strong relationships with top level officials from CFDA, CMDE, and NHFPC (formerly Ministry of Health)
  • Close collaborations with top KOLs, statisticians, and healthcare institutions

Past Projects:

Shire

CFDA lobbying: high level CFDA engagement for registration and clinical trial of controlled psychotropic pediatric drugs
KOL recruitment and management: select KOLs for advisory panel / clinical protocol design
Advisory board management: Identify critical issues, influential experts, implement & manage Shire’s medical strategy for Hematology, GI and ADHD
Clinical trial management: identify clinical investigators and provide issue management assistance
Coordination and communication: facilitate communication between the global Shire team and local clinical trial lead or PIs and regulators
CFDA registration: dossier preparation and submission

 

Sonexa Therapeutics Sonexa

KOL mapping and management: provide KOL mapping, select KOLs, establish product advisory panel for clinical trial, organize investigator’s meeting, conduct investigation center selection
CFDA Clinical Protocol Development:
recruit investigators, organize and implement a clinical advisory panel to develop China clinical protocols (significant modification of U.S. FDA protocol), obtain protocol endorsement from top KOLs and CFDA advisory panel members
CFDA registration and consultation: registration of Class 1 new drug for Alzheimer’s Disease with CDE of CFDA