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

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

• 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

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)