Our know-how
How we help you
salamanderU supports you from defining your needs to bringing your products to market. This means we consider every aspect of your project, from analyzing your needs to verifying that your facilities and products comply with all applicable regulatory requirements.
An Adapted Approach
Manufacturers' needs and challenges can be extremely diverse. Companies in the research and development (R&D) phase, for example, must be able to develop quickly, at low cost, and determine how to scale over time. Companies in the commercialization phase or with products already on the market, on the other hand, must reinvent themselves to control costs, maintain a competitive advantage, and upgrade to meet regulatory requirements.
Unique Solutions
Unfortunately, available solutions aren't always as original and unique as the challenges encountered. This is where salamanderU comes in. We are, above all, a project partner that meets all the specific needs of a manufacturer. While guaranteeing superior quality, we are dedicated to each project and provide customized solutions at affordable prices.
Flexibility
Our multidisciplinary team of experts, specialized in engineering, our business knowledge, and our technological know-how allow us to adapt—like a salamander—to any situation. That's why we always offer innovative and relevant solutions to meet our clients' challenges.
Our support
The ways we support your projects
Expertise & support - interim or not
We can provide you with a project manager, a quality assurance manager, an operations manager, a project engineer, etc.
An extensive network
SalamanderU has a wide network to handle market research, reimbursement applications, CTA, manufacturing items, subcontractors, etc.
Development and preparation of CMC files
We can provide resources and methodologies and develop the skills of your staff:
- Business strategy and global project management
- Quality and regulatory affairs management
- Engineering and maintenance
- Development and manufacturing of CMC
Guidance & coaching
Value Pack, risk register, TPP, PMO, competitive landscape, quality system, validation, business continuity, QBD, manufacturing strategy and operation, QC operation...
Engineering & Maintenance
Our support goes beyond the delivery, installation and validation of our technology and digital solutions.
It covers the entire life cycle of your project:
- Design phase
- Clinical study phases
- Commercial phase
- Continuous improvement of your installation
Project Management and Regulatory Affairs
No matter what stage of your project you are at, salamanderU can help you:
- Exploration phase
- Preclinical trials
- Early or late development
- Submission of application and launch
- Life cycle management plan
From Your Needs to Regulatory Inspection
We take into account all aspects of your project, from analyzing your needs to verifying the compliance of your installations and products with all applicable regulatory requirements.
Are you interested in our solutions?
Let's discuss your operational challenges together. Whether it's to optimize your processes, strengthen your compliance, or digitize your operations, we're here to support you.