Services
From development to finished product, as a full-service CDMO partner
We support your product at every stage: research and development, manufacturing, regulatory affairs and project management.
Development
Our Development department has extensive experience in:
- Laboratory batches
- Pilot and engineering batches
- Scale-up processes
- Manufacturing process analysis and improvement
- Manufacturing process validation
- Technology transfer of manufacturing processes and analytical methods
- Stability studies under ICH guidelines
- Manufacturing, quality control and batch release of investigational pharmaceutical products
Manufacturing
We carry out manufacturing and packaging of gels, creams, liquids, capsules and powders. We provide efficient solutions tailored to your needs, including high quality and on-time delivery.
Our 4 pillars are:
- Individualized adaptation to each project
- Flexibility in batch sizes
- Precision and rigour in every project’s timelines
- Technology transfer across different dosage forms
Regulatory affairs
Development
- Regulatory strategy evaluation
- Stability specifications and protocols definition
- Preparation of quality documentation for the application for clinical trials (Investigational Medicinal Product Dossier)
- Registration Dossier Quality Module preparation
Technology Transfer
- Strategies and advisory services design, including the evaluation of the technical transfer program
- Preparation of the necessary documentation for the dossier variations related to the transfer process
Lifecycle management
- Reclassification, reformulation, and line extensions of products strategies design
- Necessary documentation for post-authorization variations preparation
- We optimize timelines and maximize your chances of success, thereby contributing to achieving the overall objectives of your project
Project management
We analyze your project's needs and requirements. We work with a clear methodology, with detailed milestones and KPIs, for a close, agile and reliable collaboration.
- 1
Client briefing: we jointly set the priorities, the primary and secondary objectives and the project scope.
- 2
Planning: we determine responsibilities, budget, timelines (schedule) and risks.
- 3
Execution: we coordinate and carry out the assigned tasks to deliver the planned milestones
- 4
Performance and Control: we monitor project progress using the previously defined KPIs
- 5
Closure: we jointly evaluate the results, formalize the handover and document the relevant facts