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
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.
Adaptability, flexibility. All work done in Customer’s environment. Solutions proactiveness regarding:
- nearshore low-cost resources
- processes optimization with innovative solutions
August 30, 2021
