Auctris Life Sciences, specialized in managing critical Development and Operational situations within Pharma and Biotech,
- Finds solutions to challenges on portfolio, product development, manufacturing and quality to secure business continuity and achieve your Company objectives.
- Combines strategic vision of the business needs with practical insights and hands-on Development, Operations, Quality and Regulatory compliance requirements
Portfolio and Development
- Support to strategic decision on your Organization or Portfolio
- Implement Strategy or new organization
- Identify Development Options and priorities for your Portfolio
- Accelerate and de-risk Development projects facing delays or roadblocks
- Improve the productivity of Development
Examples of Realizations
Established/led several new organizations including Portfolio Management, Product Development, Project Management, Manufacturing Operations, Devices and Quality Assurance
Led several multidisciplinary Product development project teams from early development phase to late Development phase and approval
Set and developed several Life Cycle Management Portfolio for Drugs and Devices
Developed successfully several Biotech processes, Biological Products and Devices and secured approval and launch.
More than 40 products developed, from as early as lead compound up to market and life cycle management of Products, including Drug, Biologics and Devices.
Manufacturing Operations and supply to market
- Find root cause and solutions to product failures within Operations and bring process under control
- Resolve Manufacturing issues and re-establish product supply to market in full compliance
- Build efficiencies within Operations to improve your Gross Margin or increase capacity while securing full compliance
Examples of Realizations
Put in place/led successfully several new organizations including Portfolio Management, Product Development, Project Management, Manufacturing Operations, Devices and Quality Assurance
Found solutions to secure or re-establish supply to market of critical failing Products and Devices and maintain business continuity.
Rolled out Total Quality Management and Lean Six Sigma programs within Operations to drive efficiency programs and improve Gross Margin, Quality and reliable supply
Developed methodologies tailored to the needs of the Company including Root Cause Analysis, Process Control and Process Improvement which contributed to secure quality and supply of products and improving Gross Margin.
Quality Assurance and Compliance
- Streamline Quality Systems while securing full compliance throughout Operations
- Secure readiness for Pre-Approval Inspection
- Resolve critical compliance issues and put back Operations into full compliance (Critical 483’s, Warning Letters, Consent Decree)
Examples of Realizations
Put in place/led successfully several new organizations including Portfolio Management, Product Development, Project Management, Manufacturing Operations, Devices and Quality Assurance
Developed and implemented new streamlined Quality System to achieve simultaneously full compliance and efficiency
Put in place Compliance programs and prepared operating sites to pass successfully all regulatory inspections including FDA and EU.
Regulatory
- Support/Drive preparation of file for submission or resolution of critical questions from Regulatory agencies
Examples of Realizations
Led preparation of several files for submission and responses to critical questions from Regulatory agencies (EU and US) and drove support to submission up to approval and launch to market.
