COMPLIANCE & PERFORMANCE
Share
Scientific and technological advances, new business models and evolving regulations are transforming the Life Sciences industry. To succeed, industry players need a multidisciplinary partner with a global approach.
-
$1250Bn
Total pharmaceutical industry revenues in 2019
-
15%
R&D spend in 2019
-
20-30%
Of total industry’s revenue invested in quality every year
Meeting the challenge
Life Sciences are an increasingly challenging environment. Companies need to manage biotransformation, master compliance and transform the supply chain and industrial assets. At the same time they need to adapt the sales model, manage mergers as well as the globalization of activities.
The partner of choice
With unique expertise in compliance management, regulatory affairs, and quality assurance, our cross-industry best practices in process excellence demonstrate measurable and robust results.
- We leverage local capabilities in all major geographical areas to support our clients globally.
- We have a results-oriented approach from diagnosis to implementation, combining in-depth expertise in Pharmaceutical/ MedTech Regulations.
OUR KEY OFFERS
-
PROCESS & COMPLIANCE EXCELLENCE
Best-in-class consulting services to optimize core business processes in R&D, manufacturing, quality control, regulatory compliance & distribution. A results-oriented approach supported by strong change management.
- Cycle time acceleration
- Master compliance & improve performance
- Right-first-time on the shop floor
- Quality carve out / integration
-
COMPLIANCE 4.0
From design of process digitization strategies to implementation of cutting-edge digital solutions. Enhance processing, monitoring and mastery of your compliance activities to improve performance and reduce costs.
- Compliance activities automation
- Quality processes digitalization
- Digital Control Tower
-
COMPLIANCE TRANSFORMATION TO MANAGED SERVICES
Decrease TCO (Total Cost of Ownership) by shedding time-consuming context processes to handle growing quality expectations and shorter lead time, adapt to an ever-changing regulatory framework while optimizing your compliance with our tailored & agile process transformation approach for Pharma/Med Tech companies.
- Regulatory Affairs
- Quality Assurance
OUR SUCCESS STORIES
-
-
1
-
Global Vaccine Manufacturer
QUALITY SYSTEMS OPTIMIZATION
After an FDA inspection pointing out the high level of human error due to the weaknesses of the quality systems of a Global Vaccine manufacturer, we redesigned the documentation and training systems using innovative methods, resulting in a 30% reduction in human error and an increase of the efficiency rate of documentation from 15% to 70%, while ensuring full compliance with government requirements.
-
-
-
2
-
Lundbeck
PROCESS & QUALITY OPTIMIZATION
To support the client in optimizing its processes and obtaining FDA certification, we defined a three-year road map to enhance site performance and compliance through a progressive approach with quick return on investment.
Lundbeck followed our recommendations for the implementation of both a new deviation management system and a new documentation structure. Deviations were cut by 25%, and missed deadlines divided by six.
-
-
-
3
-
Pharmaceutical Company
PROCESS DIGITALIZATION
We assisted a pharmaceutical company in the digitization of its quality processes, focusing on the self-inspection process. After a detailed analysis of the current process, our team identified process improvement possibilities and defined a digitization opportunity study.
Within a few months, implementation of the recommendations led to a 20% reduction in cycle time, a 15% cost reduction and 100% auditor satisfaction.
-
-
-
4
-
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 managed CMC and Safety variations, labels/artworks management and PQR reviews 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.
-
-
-
5
-
Global Vaccine Company
PERIODIC REVIEW
We implemented 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% reduction in TCO (+€10m/y) with continuous improvement through monitoring of KPIs and ability to manage workload peaks.
-
READ MORE
White Paper
A paradigm shift to optimize quality systems
Optimizing documentation and training through an operator- centric approach
Download
