Area of Expertise |
Background |
Corporate Experience |
Clinical Study |
Clinical Experts Experienced in: Major Pharmaceutical Company as Director (2); Medical Device Company as Leader; and Manager. |
- FUJISAWA
- ASTELLAS
- MEDTRONIC
|
Developmental Regulatory Affairs (RA) |
M.D., RA Expert Experienced in Major Medical Device Company as Director; and RA Expert. |
|
Project Management, Developmental RA, and Marketing Analysis |
Ph.D.-level R&D Project Manager with experience at Major Pharmaceutical Companies. |
|
Handling Safety Information on GCP and GVP |
Ph.D. Expert responsible for Handling Safety Information at Major Pharmaceutical and Medical Device Companies. |
|
Preclinical Development Group |
Biopharmaceutical Product & Pharmacology |
Ph.D. Experts (2) with experience at Major Pharmaceutical Companies. |
- GENENTECH
- ROCHE
- FUJISAWA
- ASTELLAS
- TANABE
|
Toxicology |
Authorized Toxicologist with Ph.D. and experience at Major Pharmaceutical Companies. |
|
ADME |
Professor and Ph.D. Expert, both with experience at Major Pharmaceutical Companies. |
|
CMC(Dosage form, Spec & Test Method) |
Ph.D. Experts with experience at Major Pharmaceutical Companies, one as Manager and Director of an Industrial Institute. |
|
Quality Assurance Group |
GCP Compliance |
GCP Audit Expert/Pharmacist with experience at Major Pharmaceutical Companies. |
- BOEHRINGER INGELHEIM
- SCHERING AG
|
GMP Compliance |
GMP Audit Expert/Pharmacist with experience at Major Pharmaceutical Companies. |
|