Dendritic cell vaccine (oncology)

The Challenge

The Challenge

Client in need of expert support to align development strategy with EU authorities’ expectations. Timeline: long-term (8 years)

Support in

  • Preparation and conduct
    of the Scientific Advices (SA)
  • Medical and technical Writing
  • Clinical trial Phase III
  • Adaptive pathway
  • Early access medicines scheme
  • Hospital exemption (DE)
  • Pediatric Investigational Plan (PIP)
  • Pharmacovigilance: DSUR and PSUR
The Solution

The Solution

Senior project lead supported by subject matter experts with know-how of special programs.

PharmaLex Project Leader as main point of contact for the customer:

  • Contact point for all questions
  • Provides strategic support
  • Overall responsibility for all deliverables
  • Coordinates the PharmaLex experts
  • Fast response times
  • Manages timelines and costs

Specific subject matter experts involved

Master service agreement in place with work orders for various deliverables/services

The Outcome

The Outcome

Positive outcome based on our 25+ years of experience with health authority interactions.

  • Experts available with ATMP experience in regulatory, quality, nonclinical and clinical aspects
  • Access to EU Health Authority opinion leaders via the extensive PharmaLex network
  • Know-how for special programs (Hospital exemption, EAMS and Adaptive Pathway)
  • Seamless integration of Development, Regulatory and PV services
  • Flexible contractual framework allowing quick implementation of new work orders

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