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Global Pharmaceutical Consultation Services
Pre-clinical consultation
- GPSI provides expert advice on protocol requirements for pre-clinical programs based on in-country requirements prior to Phase 1 testing.
- GPSI can identify contract facilities that offer a wide range of pre-clinical activities.
Clinical
GPSI provides expert advice regarding the drug development process based on a working knowledge of U.S., European and Japanese requirements and practices. This includes:
- Technical program advice
- Protocol review and revisions (English content)
- Pre-U.S. IND review of program/protocols
- Pre-NDA submission reviews and medical rewrites, and
- Coordinating scientific/medical interactions with experts worldwide within a give therapeutic field
- Clinical program reviews
- ADR review/medical recommendations/reporting
- Medical coordination/management of clinical programs between study sponsor and partner
Medical Services
- Package insert reviews and recommendations
- ADR reviews
- Program safety issues
- Program portfolio reviews
- Clinical representation in legal proceedings
- FDA/company interactions
- Clinical trial safety issues
Human Resources
GPSI specializes in assisting U.S. and non-U.S. companies considering establishing (or expanding) their presence in the U.S. We offer expert advice in all U.S. employment regulations, policies, and guidelines, as well as site location/preparation that includes demographics for labor, wages, benefits, transportation and community incentives.
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