Target Groups
Regardless of your company size, we can help you deliver on your goals. Both small and medium companies as well as large enterprises know that they can count on LVL Mediphar.
We have long-standing experience in serving several small start up companies who need a full-service package ranging from quality system start up, regulatory asssistance, production know-how, validation, medical writing, STED and DHF editing, etc.
This experience in medical devices, combined with our network of reliable partners and a practical hands-on approach, has led us to always achieve our clients' goals, timelines and expectations. A few examples:
- Implants (IUD – IOL - ….)
- Extracorporeal circulations devices (dialysis, plasmaferesis, CPBP,…)
- Drug administration device (infusion & perfusion, syringes & needles, catheters ,…)
- Surgical instruments in several healthcare disciplines
- ….
Medium-sized companies struggling with overhead and/or in need of assistance with new projects, regulatory or client requirements are served on several domains, including:
- CaPa handling
- Needing help with internal audit (with a fresh new view)
- Validation of processes
- Risk management activities
- Medical writing
- Design review & planning
- STED Technical file review
- Clinical evaluation reports (CER) and PMS review
- LVL Mediphar can act as interim quality representative or RP for GDP regulatory compliance
- ...
Large corporations in need of specific project leaders are always welcome to discuss their needs. LVL Mediphar has experience in both GMP medicinal products and medical devices and has focused on coaching internal or new hired people to accomplish their tasks in several topics, for example:
- Training needs
- Product regulatory status compliance
- Drug – device combinations
- PMS / PMCF and Vigilance
- ...