Product category: Logistic services, Planning services, Consulting for health organisations, Conduct management, Personnel advice and planning, Planning of building technology, Planning and organisation of logistics / material management, Process analyses, Safety planning and advice, Site planning, Insurance planning, Profitability consulting, Technical equipment management, Test houses / Certification Bodies, Biocompatibility testings, Certification and testing of medical devices, quality assurance
Life Sciences & Chemicals
Due to increased pressure on cost from clients and control of health expenses from governments, Pharmaceutical and Chemical industries are facing 3 broad categories of challenges:
Risk management and compliance; key topics are managing increased public & regulatory attention on standards (eg. GMP, GLP, etc...) and complying to new regulatory hurdles for new drugs approvals (eg. increasing proof of effectiveness, pharmacovigilance systems)
Production efficiency and margin pressure; key topics are developing responses to emerging low-cost & generics competition and improving production line efficiency by increasing OEE (Overall Equipment Effectiveness)
Transformation management; key topics are adapting to the new pharma model (eg. more direct communication to patient), optimizing the balance of power between laboratories and retail chain actors and, finally, pushing cost pressures down by transferring cost and responsibilities to suppliers
Our recent assignments in Life Sciences & Chemicals
Program set-up and management to increase our client process robustness in order to comply with authorities expectations and increase volumes of production.
Support R&D department in the implementation of new quality system and team coaching & mentoring to increase quality maturity mindset and inspection readiness.
Project/Program Management practices benchmark from different industries to advise on the implementation of a PMO.
Production sites validation activities coordination and follow-up in collaboration with technical services and product transfer experts.
Follow-up of international sub-contractors for production activities and management of quality aspects (deviation and CAPA management, release of commercial batches, quality system transfer...)
Management and coordination of the audit of our clients production site by several authorities (from the preparation to the answer regarding highlighted issues)
Management of a continuous improvement project using lean and/or 6-sigma methodologies at different levels of a formulation business unit (5S, DMAIC, VSM, Pareto...)