COMPLIANCE TRANSFORMATION & MANAGED SERVICES

MARKET DIAGNOSIS

Life Sciences companies must optimize time-to-market, costs and business models to remain competitive while complying to a strict and ever-changing regulatory environment.

Non-compliance can induce high secondary costs (non-released products stocks, product recalls…), delayed production, issues with authorities, and even risks for patients.

Achieving balance between compliance & costs represents a major concern for all Life Sciences players:

Compliance:

  • Constantly meet quality & regulatory requirements
  • Stay at forefront of best compliance methodologies

Cost:

  • Reduce Total Cost of Ownership (TCO)
  • Decrease efforts spent on non-core activities
ALTRAN_EMPLOYEE-YG

2x

Non-compliance costs can reach twice the cost of compliance

ALTRAN_EMPLOYEE-GR

67%

Of compliance leaders acknowledge increasing compliance investments

ALTRAN_EMPLOYEE-YG

25%

Of industry revenues are spent in total cost of compliance

OUR VALUE PROPOSITION

More than outsourcing, we transform and optimize your compliance processes, through a tailored & agile approach.

We turn constraints into value to achieve optimized costs, workload flexibility, better compliance and robust processes, while enabling our clients to focus on their core activities.

We transform your non-core regulatory & quality processes, through a tailored transformation and managed services approach, fully managing them, while ensuring a smooth transition and rapid deployment.

We provide a best-in-class approach combining:

  • Analysis of TCO before and after transformation.
  • Highly qualified consultants with strong expertise on compliance through certified delivery centers.
  • Best practices for process optimization leveraging lean methodologies, digitalization & change management.
  • Industry benchmarks with major Life Sciences players.

OUR OFFERING

We transform and fully manage context regulatory and quality processes, enabling our clients to focus on their core activities while optimizing compliance TCO & performance.

  • QUALITY SOLUTION

    Reduce TCO by getting rid of time-consuming context processes to handle growing demand of quality expectation that comes with constraining audits and remediation plans, with our tailored & agile process transformation approach.

    • Product Quality review/ Annual Product Review
    • Continued Process Verification
    • Complaint handling
    • Quality Mutual Agreement
  • REGULATORY SOLUTION

    Decrease TCO, lead-time and adapt to the ever changing regulatory framework while optimizing regulatory compliance, with our tailored & agile process transformation approach.

    • Labelling & artwork management
    • Product information variation
    • Chemicals Manufacturing & Controls writing & variation
    • License conformance

RECENT PROJECTS

 

 

OUR WHITEPAPER

WHITE PAPER

A paradigm shift to optimize quality systems

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