GVP Audits Worldwide
Introduction
US Biotechnology
Our client is a global Biotechnology company dedicated to genetics and molecular biology. They are Headquartered in the US, with offices in most major economies.
Apotech auditors
Our Auditors have 20+ years' experience in the industry and have all conducted over 100 GVP audits.
Types of Audits
- Affiliate
- Distributor/ PV Partner
- Specialty Pharmacy with REMS
- Market Research Vendor
- Social Listening Vendor
- Patient Support Program Vendor
Audit Locations
- USA (5 states)
- Iran
- Puerto Rico
- Oman
- Taiwan
- Saudi Arabia
- Chile
- South Korea
- UK
- Germany
- France
Scope of work
Responsible for managing and delivery of our client’s full yearly GVP vendor audit program
All audits are within GVP
Project Manager liaising directly with vendors and sites to arrange dates and pre-audit meetings
Responsible for planning the schedule and costs of the following year's audit plan
28 audits across each year
Apotech delivery team consisted of a Senior Project Manager, Business Manager and a team of 6 Auditors
Conduct of the audit, initial meeting, interviews with key members of the site, review of documentation and exit meeting
Key numbers
Team
1 Project Manager and 7 Auditors
Location
Worldwide
Length
3 Year Contract
Type
Full Service Provision