BIOMANUFACTURING ADVISORY SERVICES
Unizima strives to provide the right tools and expertise needed to address the specific challenges our clients face in their mission to establish a successful and sustainable bioproduction project.
Our industry team experts provide a comprehensive assessment of your biomanufacturing project based on the skills, systems, capabilities and financing needed to complete a specific bioproduction project. Our data-driven approach helps you understand local market opportunities and how to best capitalise on them.
- Market and opportunity research
- Resource and capacity estimations
- Economic viability estimation (business case /NPV)
- Implementation programme and strategy
- Risks/challenges and mitigation planning
- Process flow diagrams
Unizima serves as a strategic partner for long-term value creation through in-licensing of target bioproducts. We apply a stage-gated process that allows for optimal flexibility, rapid opportunity identification and screening. Acting as a trusted entity between our clients and licence holders, we accelerate timelines for obtaining product licences.
Our QMS package is developed in full compliance with the GxP regulations of each country. Unizima can address specific Quality-related requests or even provide the set-up of a full QMS, consisting of policies, manuals, standard operating procedures, work Instructions, forms and templates.
Additionally, through the implementation of QMS for clients, Unizima:
- Serves as a point of contact for queries related to quality & compliance
- Assists with third-party management (qualification & assessment/audits)
- Assists with quality risk assessment to identify gaps/risks and proposes an adequate Corrective and Preventive Actions (CAPA) plan
- Provides QMS training to employees
Unizima’s agnostic approach based on careful planning and risk-based management, in combination with our team of experts, enables you to reproduce the transfer product/process from the beginning, delivering the desired level of performance and meeting regulatory expectations.
• Our TT team can plan and coordinate the transfer, acting as the technical point of contact between sending (SU) and receiving (RU) units.
• Our TT services include executing the analytical transfer and TT runs (dry, wet, engineering) of the production processes[GS1] , up to PPQ/process validation if needed.
MEET OUR TEAM OF EXPERTS DELIVERING INTEGRATED SERVICES