Generics manufacturer global support

Customer Profile 

Pharmaceutical company of generic human medicinal products. PLG project scope: all medicinal products registered in France. This represents about 900 MAA with a large panel of stakeholders inside Customer organization and through its supply chain 

PLG is in relation with a member of the Executive Committee, the “Directeur des Affaires Pharmaceutiques – Pharmacien Responsable” 

PLG managers are in front of Customer transversal managers having responsibility for Regulatory Affairs, CMC & Compliance on a segment of products 

PLG is the interface, for its activities, between the Customer and its 150+ manufacturing suppliers 

PLG is in charge of post MAA Regulatory Affairs, CMC, Compliance & Quality 

 RA = DOCUMENTS WRITING 

• RA Intelligence on medical information updates 
  (Labs to Authorities) with client validation for updates 
• Variation documents preparation for Submission 
• (Customer is in charge of relations with Authorities) 
• After Approval, updates of artworks 
• Pharmabraille instructions validation 
• Update of internal documentation according to 
  updated SmPC 

CMC 

• Manufacturers data collection / 
  MAA dossiers management 
• MAA variations writing 
• Relation with Manufacturers for approved dossiers  

QUALITY 

• Compliance of manufactured medicines by Manufacturers / CMO with MAA dossiers 
• Drugs sustainability study results analysis (stability) 
• Customer requirements (to the Manufacturers) updates (quality agreement) 
• PQR analysis 

The Customer is coping with: 

• a high quantity & variety of drugs data  
• evolutions inputs are complex: they might come from Regulatory constraints or evolutions; manufacturing data update, either coming from the manufacturer or from the Customer; drug information evolution, either coming from labs or regulations 
• they require a very flexible and reactive team when peaks of activities 
• the Customer would like to create synergies if the evolutions impact more than one activity (RA, CMC, Compliance, Quality)