Customer Understanding

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’s responsibility & activities

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 

Customer Challenges

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) 

Added-value and customer benefits

  • Customer benefits 

Single supplier management for 4 domains, with possible information synergies between RA & CMC. 

CMC + Quality relations to Manufacturers coordinated & simplified. 

High quality for low price. 

 

  • PLG added-value 

Adaptability, flexibility. 

All work done in Customer’s environment. 

Solutions proactiveness regarding:  

  • nearshore low-cost resources 
  • processes optimization with innovative solutions 

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