Consulting Areas:
Strategy Development:
Medical Affairs
Regulatory Affairs
Clinical Operations
Business Operations
Clinical Research
FDA Meetings
Education&Trainings
Changing the global healthcare, one step at a time...
International Consulting Company, specializing in Medical Product Development. We provide Medical & Regulatory Affairs Services and Scientific Consultations to Life Science Industry.
Contact us and we will help you to develop the right strategies for your company...
CRO Services:
Medical Writing
Regulatory Submissions
Clinical Trials Phase I-IV
Clinical Trials Management
Clinical Site Selection and Audit
CRA Services
Data Management
Quality Control/Quality Assurance
Business:
Medical Marketing
Market Research
International Market Analysis
International Market Mode of Entry & Strategy
By Industry:
Pharmaceutical
Medical Devices
Biologics
IVD, Laboratory Diagnostics
By Regulatory Agency:
FDA
EMA,MDD (EU)
MHRA (UK)
WHO
Canada Health
TGA (Australia)
Roszdravnadzor (Russia)
SFDA (China)
MHLW(PMDA&PAL) (Japan)
CDSCO (India)
KFDA (South Korea)
TFDA (Taiwan)
MDCD (Malaysia)
HSA;CDA (Singapore)
ANVISA (Brazil)
COFEPRIS (Mexico)
INVIMA (Columbia)
ANMAT (ARGENTINA)
Standards:
ISO
cGMP
GCP
GLP