Regulatory Affairs

 

We assure:

  1. Close attention to our clients’ needs

  2. Flexibility

• Respect of deadlines

• Confidentiality

  Your goal is ours: Registration file approved by the authorities concerned
 
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We can help you in all aspects of Regulatory Affairs in France and elsewhere in Europe: 

  1. Writting of Pharmaceutical and Clinical Dossiers

  2. Marketing Authorization Applications (including e-CTD submissions)

  3. Regulatory strategy and advice

  4. Audit of dossiers and regulatory portfolios (due diligence)

  5. Writting of PSUR and RMP

• Lifecycle management (pharmaceutical, product information and clinical variations, renewals benefit/risk evaluation...)
• Summary of product characteristics (international comparison, update, translation,...)
• User testing
• Regulatory clinical support, etc.

  Our consultancy service covers all healthcare products
 
  The team
 

As a true partner of the pharmaceutical industry, MediBridge proposes for its information
“The Letter of MediBridge”, a short document addressing key regulatory issues of current interest relevant to healthcare products. If you would like to download these publications, click here.

The Letter of MEDIBRIDGE
 

The Medibridge Regulatory Affairs team is made up of pharmacists, physicians, and PhD scientists who have good relationships with the Authorities.


If you wish to know more about MediBridge Regulatory Affairs please contact:

Regulatory Affairs Director

Saholy Rakotomanga
CV & publications
s.rakotomanga@medibridge.fr

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