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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
Frame 1000005946

Scope of work

Responsible for the delivery of regulatory and clinical services and resources. The scope of the services include:

Done

Lifecycle management activities, including variations, renewals and labeling

Done

Clinical Trials (IND, CTA, and IMPD)

Done

Clinical Monitoring

Done

Clinical and non-clinical regulatory medical writing including IBs, CSRs, narratives and clinical development

Done

Marketing Applications (NDA/BLS, MAA, NDS, etc.)

Done

GCP Audits

Have a project in mind_ Let’s work together!
Full testimonial available upon request

I would certainly recommend Apotech. They offer complete added value. Apotech take the time to investigate how you work as a business and align with your structures in a way that is minimally disruptive. This bespoke and flexible approach makes for a positive strategic partnership that ultimately leads to successful outcomes.

Key numbers

Management

Team

18 consultants

Charity

Location

global

Combo Chart

Length

3 years 

WeChat

Type

hourly rate 

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Contact us today to find out how we can support you in your next project.

Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.