Global in-country regulatory support
Introduction
Top 3 Global CRO
Our client is one of the largest CROs globally, with operations present in every economy. Their services range from Clinical Development, Medical Affairs, and Commercial Delivery. Apotech continues to partner with them on a 3-year FSP contract.
Apotech’s Consultants
Our 18 strong Consulting team includes a mixture of clinical and non–clinical regulatory professionals, all with a minimum of 15 years experience located globally.
Locations
- UK
- Germany
- France
- Belgium
- Turkey
- Austria
- Germany
Scope of work
Responsible for the delivery of regulatory and clinical services and resources. The scope of the services include:
Lifecycle management activities, including variations, renewals and labeling
Clinical Trials (IND, CTA, and IMPD)
Clinical Monitoring
Clinical and non-clinical regulatory medical writing including IBs, CSRs, narratives and clinical development
Marketing Applications (NDA/BLS, MAA, NDS, etc.)
GCP Audits
Key numbers
Team
18 consultants
Location
global
Length
3 years
Type
hourly rate