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:
- Constantly meet quality & regulatory requirements
- Stay at forefront of best compliance methodologies
- Reduce Total Cost of Ownership (TCO)
- Decrease efforts spent on non-core activities
Non-compliance costs can reach twice the cost of compliance
Of compliance leaders acknowledge increasing compliance investments
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.
We transform and fully manage context regulatory and quality processes, enabling our clients to focus on their core activities while optimizing compliance TCO & performance.
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
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
FRENCH PHARMACEUTICAL COMPANY
OUTSOURCING PHARMACEUTICAL COMPLIANCE ACTIVITIES
We supported the client in outsourcing its compliance context activities through a progressive transfer to our nearshore delivery center while ensuring business & compliance continuity and quality of service. A team of 25 consultants manage CMC and Safety variations, labels/artworks review and PQR from over 120 Contract Manufacturing Organizations (CMO). The project resulted in a 50% cost cut in regulatory affairs, GMP and PV activities and better CMO management & compliance.
GLOBAL PHARMACEUTICAL LEADER
QUALITY COMPLAINTS HANDLING
Due to new regulations for Combination Products, we supported the post-marketing surveillance department of our client in migrating market complaint handling activities to a new platform (TrackWise). We implemented a managed service team to handle the additional workload, eliminating the existing backlog and handling the day-to-day complaint handling operations. We achieved a 60% cost reduction & provided business oversight for our client complaint processes.
GLOBAL PHARMACEUTICAL LEADER
PRODUCT QUALITY REVIEW & CONTINUED PROCESS VERIFICATION
We optimized and performed the PQR including the identification of continuous improvement CAPAs and managed the quarterly report of Continued Process Verification. We have been progressively transforming the PQR activities to a managed service approach leveraging our compliance global engineering center.
After implementing the service, we achieved a 60% cost reduction & a harmonized way of working across >10 international production sites.
GLOBAL VACCINE COMPANY
We implemented an end-to-end documentation delivery with a front-office at the client site and back-office in a nearshore location for periodic review activities.
We leveraged outsourcing with Industrialized GlobalShore® to handle the client’s activities in a service contract.
The project resulted in a 40 to 50% TCO reduction (+10€m/y) with continuous improvement through monitoring of KPIs and ability to manage workload peaks.