Regulatory Affairs

MEDIPHA SANTE offers pharmacovigilance services which include : preparation of rmps (risk management plan), 
ccountability by the begaud method, 
coding of adverse events according to meddra.
Medipha Santé can act as local responsible for pharmacovigilance (local qppv) and as a loca...

MEDIPHA SANTE offers Quality Assurance services which include : 
Management of quality system documentation
Management of quality topics  (Complaints, Change Controls , Deviations  CAPAs, Training, Product Quality Review, Quality Indicator, Quality meeting, Risk analysis...

MEDIPHA SANTE offers a wide range of business development services which include:. 
Evaluation and assessment of your needsIn-licensing & out-licensing of the product portfolio, 
optimization of authorized activities
Market access strategies
Seeking business and partnership oppo...

MEDIPHA SANTE offers a wide range of services which include: 
StrategyCompliance with the requirements for every type of variation
Preparation of supporting documents
Submission of variations according to the appropriate procedure
Renewals
Pharmacovigilance (Medipha Santé can provide ...

MEDIPHA SANTE offers a wide range of services which include:- providing all the activities of an “Exploitant” company on the French market for French companies or foreign companies that do not have a pharmaceutical establishment in France
- assistance in the creation of a French subsidiary of your...