login
HOME TEAM SERVICES DRUG DEV. BUSINESS DEV. REGULATORY CLINICAL TRIALS CASE HISTORY CONTACT MED. DEVICE


 Intro 8

                    

ISO 2008

Charlot  Services

 

For companies which do not have or cannot dedicate internal resources and infrastructure for the Development of their candidates, Eudax’ expert team can offer the skills required to manage inherent complexities of Drug and Medical Device Development, including Technical, Regulatory, Operational and Legal knowledge.   

 

 

 

For our clients, having a comprehensive suite of capabilities and expertise encompassed in a single project management system, optimises the development plan, eliminates barriers and ensures delivery in the shortest possible time.

   

For a non-EU based company, Eudax can accomplish the task as its European subsidiary…


We are pleased to propose ourselves as the bridgehead to Europe for non-EU based companies interested to plan and carry out the Development of their candidate Drugs or Medical Device in the EU, which will allow them to plan for the establishment of their European subsidiary or to negotiate license terms, while building asset value in Europe. Indeed, Eudax can operate as your European office in many respects:

  • Advising about the strategic approach to the European market
  • Helping in drafting the Drug Development Plan
  • Implementing the Plan, coordinating non clinical and clinical studies, managing the relationship with suppliers and CROs
  • Liaising with European experts, coordinate Scientific Advisory Board
  • Liaising with EMA and national Health Authorities providing Legal Representation (authorization for clinical trials, Orphan Designation, Scientific Advice and MAA)
  • Establishing contacts with potential partners/licensees

 

How do we operate?

From the early stages of clinical candidate selection we proceed as follows:

1. We start with the Gap Analysis.
2. Development Program: we plan together with our client how to get timely, accurate and accessible data in order to reach critical decisions that affect the development of the candidate drug.
3. Then, we manage the implementation of the program and the execution of the studies both using our in-house skills and facilities and through our pre-qualified and selected network of suppliers/partners (e.g., Academic Research Centers, Contract Labs, CRO).

 

 

All in all,

  • We offer you a flexible and customized solution
  • You are guaranteed to receive professional and unbiased advice on how to select the right suppliers to satisfy your needs
  • We can manage the execution and implementation of your project 
  •  We strive to offer a cost effective service