OUR
Customers
Our customers range from large multinationals, through to small one person startups. All of which need to find efficient ways to comply to the latest regulations for medical and pharmaceutical products.
Startups
We advice small companies on best practices to maximize the change to bring successful products to market.
- Develop funding plan
- Refine product concept
- Develop project and compliance plans until launch
- Ensure proper and complete technical file documentation and drive local and global registration
- Identify payers and develop distribution
- Set up and certify quality management system.
- Implement and faclitate core business processes (such as document control)
- Act as PRRC, CT and other key roles.
Operations
For more established companies we help with opening up new opportunties and filling resource gaps.
- Remedition and process improvements
- Bring existing products to new markets
- Manage operative QMS (such as document and change control, capa, complaints, NCs)
Vision
Be the partner of choice for companies operating in medical device, vitro diagnostics and the pharmaceuticalsectors.
