Life Science Experts
Consulting and staffing in the Life Science, regulatory, IT, supply chain, lean management, R&D and validation areas given by senior personnel.
We adopt a digital approach. We implement and transform the digital strategies elaborated during the product briefing in agreement with the stakeholders.
With our approach we analyse the scenarios that have the greatest impact in terms of global business through IT solutions that provide quantifiable data, with reference benchmarking in relation to company projects, also considering ROI and optimizing the quality-price ratio. Through careful and functional project management, we implement solutions and methods centred on the data.
We provide current concrete solutions and solutions projected towards the future in both functional and technological terms.
PHARMA PRODUCTS & BUSINESS DEVELOPMENT
Pharma & Product Business Development was set up to enhance the value of technical skills in the development of pharmaceutical products understood as a set of processes.
We provide a strategic vision in the company process planning and implementation phase oriented towards “Digital Transformation and IoT”.
We provide consulting services, including staffing, both in the GMP and ISO environments, supporting companies in the application of Quality Risk Management (QRM) and Quality by Design (QBD) to all company processes.
In relation to the marketing authorisation phase, for the post marketing of human, veterinary, homeopathic and cosmetic products, we elaborate and identify the most suitable regulatory strategy for the purpose.
We offer support in the development, industrialization, optimization and validation of pharmaceutical processes in accordance with the reference standards (DOE, FMEA, QbD, PAT, ICH q8/ q9/ q10, ASTM, ISO).
We draw up and implement qualification protocols valid for all processes and the activities carried out on the pharmaceutical production plant.
& LEAN MANAGEMENT
We work in close collaboration with company management to conduct an in-depth analysis of their organizational models with a view to improving their performance and manufacturing processes significantly.