OUR SERVICES
AT AIXILIA
Please find some examples of executed projects and fields of support for the success of your business
Product Transfers
Projects, successfully executed:
- Managing a Product Transfer (EU wide) with approx. 250 SKU’s
- Managing several Drug Substance and Drug Product Transfers within R&D (EU)
- Supporting Product Transfers in Technical Operations within EU and globally for Technical Operations
- Product Transfer of C-14 sterile product within R&D (EU)
Technical Operations
What we can offer for Drug Substance and Drug Product, e.g.:
- Challenge/analyze the current overall operations strategy and providing/calculating alternative options.
- Project Management within Technical Operations
- Support teams in implementing or optimizing new processes and/or operational excellence modules
- Reviewing the effectiveness of current business processes
- Managing the interface Quality/Manufacturing.
Any other topic not mentioned above, please don’t hesitate to contact us.
Research and Development
Our experts help speeding up your development with additional support in Technical Project Leadership, in Analytics and CMC.
- Technical Project Management throughout clinical phases
- We have special expertise in managing the Transfer/Interface from Development to Commercial Manufacturing for your products
- Analytical Project Management during Development and Commercialization
- Alliance Management and Troubleshooting
- CMC document preparation throughout all clinical phases
Any other topic not mentioned above, please don’t hesitate to contact us.
Quality/GMP
What we can offer for Drug Substance and Drug Product e.g.:
- Finding pragmatic solutions for QA requests in the manufacturing areas in close collaboration with the respective units
- Support to implement the adequate quality strategy in R&D and operational areas for Analytics, Drug Substane Synthesis and Drug Product Manufacturing.
- Evaluate current Quality Strategy to identify potential for Optimization.
- Evaluate new supplier’s/CMO’s Quality Strategy during initial visits (prior GMP audit)
- GMP auditing
Any other topic not mentioned above, please don’t hesitate to contact us.
Interim Management
Positions that we can offer, e.g.:
- Site Director
- Head of:
Production, QC/QA, Technical Development, Manufacturing & Sciences, Analytical Development and several similar positions. - Project Management:
Technical PM R&D and Operations, Analytical PM R&D and QC, QA PM, Validation PM
Any other position not mentioned above, please don’t hesitate to contact us.