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

  • Manufacturer’s 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

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 success factors

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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MAH global support : RA, QA, CMC Credentials related to the RFP