salamanderU accompanies you from your need to your regulatory inspection. This means we take into account all the aspects of your project, from analyzing your needs to making sure your installations and products comply with all applicable regulatory requirements.
We can provide you with a Project leader, Project manager, QA, Operation manager, QP ad interim, Engineer project leader,…
We guide you along the project with our best practices, templates and coaching, for example regarding: value pack, risk register, TPP, PMO, competitive landscape, Quality system, validation, business continuity, QBD, manufacturing strategy and operation, and QC operation.
salamanderU has a broad network to take care of market research, reimbursement files, CTA, manufacturing items, sub contractors,…
No matter which stage your project is currently in, salamanderU can support you. Whether you’re in an exploration stage, doing preclinical phase trials, early or late development, ready for filing and launch or working on a life cycle management plan.
More particularly, our support goes beyond the delivery, installation and validation of our technological solutions (tailor-made isolators) and digital solutions (voice-controlled eBRs). It covers the entire life cycle of your project, from the design phase, clinical studies phases and the scale-up phases to the continuous improvement of your installation.
Aside from our technological and digital solutions, we can provide resources and methodologies and develop your staff’s skills in four main areas: business strategy and overall project management, managing quality and regulatory affairs, engineering and maintenance and finally CMC development and manufacturing.
