CONSULTANTS
Manufacturing and Analytical | ||||
Process engineers | Facilities design engineers | API chemists | Analytical chemists | Drug Product and formulation chemists |
Project managers | Validation experts | Contract laboratory managers | Protein chemists | Bioanalytical statisticians |
Nonclinical | ||||
Preclinical Scientists | Toxicologists | PK statisticians | Scientific writers | Technical writers |
Clinical | ||||
Clinical scientists (MD and PhD) |
Clinical operations managers | Project managers | Monitors | CRF designers |
Clinical safety monitors | Clinical statisticians | Medical writers | PK statisticians | |
Quality | ||||
Quality managers | QA auditors Devices | QA auditors GCP | QA auditors GLP |
QA auditors GMP |
QC specialists | Laboratory compliance experts | Technical writers | ||
Regulatory | ||||
Regulatory Operations Managers | Regulatory Affairs professionals – Drugs | Regulatory Affairs professionals – Biologics | TPP/Labeling experts | Regulatory Submissions eCTD and CTD (paper) |
Technical writers | ||||
Other Business Support | ||||
Due Diligence | Business Development | Translation | Technical writers and editors |