Our company offers various types of consultancy in the Pharmaceutical and Life Sciences fields in general through a network of professionals with experience decades of experience in leading multinational companies in Executive positions. In a constantly evolving market, such as the pharmaceutical and life sciences ones, it is essential to have a reliable and competent partner at your side who can provide high-level advice and support.
Lean Institute Italia is a point of reference for pharmaceutical and life science companies that wish to improve their performance and achieve business objectives.
The activities range from product development and process development and product industrialization , assistance in critical remediation activities following AIFA , FDA or other international drug agency inspections. Support in the Concept Design of new industrial plants and laboratories, combining GMP aspects with the concepts of Lean Manufacturing and Operational Excellence (WCM) .
The activity of Party Technical Consultancy has recently been included in assisting law firms and companies, in the management of arbitrations with the Chamber of Commerce or in Court in civil cases, also offering preliminary opinions on possible cases.
We also carry out Industrial Due Diligence and GMP activities in evaluating Critical Deviations on products and processes or GMP or Regulatory Deficiencies, providing through a Multidisciplinary Team the analysis of the causes, highlighting the GAPs and proposing remediation plans for the Pharmaceutical and Medical Devices sectors and Life Sciences.
Our decades of experience and the presence of a network of qualified professionals allow us to apply risk analysis to products and processes, using FMEA and ICH Q9 in all industrial sectors and in particular the CCS Contamination Control Strategy according to the new Annex 1 for sterile production.
Having a consolidated multidisciplinary network and an international network , we can offer our expertise for the search for new suppliers of raw materials , or machinery for the Life Science industry, also offering the preparation of technical specifications or URS or general contracts of 'purchase.
Having a large database for training in the most varied sectors of the Life Science industry; we offer our advanced GMP training programs, but also Induction for new hires, issuing certificates of participation and/or qualification through learning assessments. Available to create customized programs on request.
We carry out rapid improvement projects (within a few weeks) through the application of the Kaizen Week tools, which include initial training of the internal improvement team, which, guided by our experts, after an initial « Actual State » analysis, designs the ideal process « Future State » and defines the methods and times of implementation, also including the ROI . We have a large number of successful projects carried out in various company sectors.
We design and implement Lean Deployment projects aimed at creating a corporate culture based on performance and the pursuit of excellence . Through initial analyzes of the context, we develop studies that highlight the economic and qualitative potential that can be concretely achieved through Lean Manufacturing and OPEX techniques .
To find out more about the services offered, visit the services section or contact us via our page.
