Global Pharmaceutical Service Offerings

Audit Services

GPSI provides independent quality assurance audits/inspections/reviews and consultation in the pre-clinical, clinical, and manufacturing areas. All audits are conducted using applicable worldwide regulations and guidelines (e.g.. Good Laboratory Practice - GLP, Good Clinical Practice - GCP, Good Manufacturing Practice - GMP).

• Pre-clinical audits/reviews/inspections: GPSI conducts facility inspections, report and raw data reviews, and FDA inspection assistance.
• Clinical audits/reviews/inspections: GPSI conducts clinical investigator site audits, final report reviews, IRB audits/reviews, Adverse Event Reporting Systems reviews/audits, and FDA inspection assistance.
• Control/manufacturing audits/reviews/inspections: GPSI conducts review of facilities, records, or systems for compliance with Good Manufacturing Practice regulations and guidelines, and FDA inspection assistance.

Training

GPSI provides seminars and in-house training programs on various topics, dependent on a client's need. These training programs can be held at an individual company or in a central location to allow for multiple company representation. GPSI training topics include:

• Standard Operating Procedures (SOPs) - consultation, reviews, writing, maintenance
• Good Laboratory Practice (GLP) - OECD, FDA
• Good Clinical Practice (GCP) - ICH, EU, FDA, WHO
• How to conduct audits
• How to write audit reports
• Monitoring
• FDA inspections (GLP, GCP, GMP)
• Clinical development process (U.S. , Europe and Japan)
• Conducting studies to GLP or GCP standards
• Informed consent (preparation and process)
• Human Resource (Employment) U.S. guidelines and practices
• U.S. Marketing techniques and tools
• How to conduct business in Japan

Liaison

GPSI presents various aspects of partnering with a foreign company to the pharmaceutical and non-pharmaceutical industry. Specific expertise includes:

• A working knowledge of pre-clinical and clinical development processes in the Far East and the U.S.;
• Coordination of communications between sponsor and client (i.e. project management, problem resolution, performance assessment, negotiations, etc.);
• Knowledge and sensitivity to various cultures;
• Introduction of U.S. companies to foreign distributors for the purpose of expanding marketing opportunities in those countries.

Monitoring

GPSI monitors activities between the Far Eastern client and their U.S. business partners and vice versa. This includes active phase monitoring (pre-clinical and clinical), performance assessment (investigator site, compliance with contract), and adherence to all applicable guidelines and policies. This service is offered for U.S. companies as well.

Technology Transfer

GPSI has global networks for licensing and acquisition activities. Within specific pharmaceutical areas, client companies are identified who have an interest in licensing a specific technology and the capability to develop that technology.

Consultation

GPSI provides assistance in the research and development of pharmaceutical products in the pre-clinical, clinical, human resources, and regulatory/compliance field.

Pre-clinical
Clinical
Medical Services
Human Resources