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Competent in the Pharmaceutical, Medical Devices and Life Sciences sectors in general, I offer a
decades of expertise from a multidisciplinary network of managers with international experience in the sector in product development, in their industrial scale up, in the creation of new processes
Sector
Pharma & Life Sciences
I put at your disposal the necessary skills to bring your products from concept design to their marketing, through the development of technical or clinical batches, stability studies according to ICH, through their industrialization up to registration.
Product Developments and Industrialization
01
We ensure maximum confidentiality when evaluating Critical Deviations on products and processes or GMP Deficiencies
o Regulatory, providing through a Multidisciplinary Team the analysis of the causes, highlighting the GAPs and
proposing remediation plans for the Pharmaceutical, Medical Devices and Life Sciences sectors.
Due Diligence for Quality Compliance
02
We carry out GMP audits for your account, both in Italy and abroad, using your Operating Procedures and vs. standards such as: Agenda, Check List, Report or proposing those we normally use. We can provide detailed action plans for supplier qualification following the entire process.
Audits and Supplier Qualification
03
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. We have followed the development of the new Annex 1 and applied it successfully.
Risk Assessment and Contamination Control Strategy
04
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 for 'purchase.
Scouting for New Technology and Suppliers
05
We offer consultancy in the development and creation of the VMP of a new process, of a new one
plant, a new laboratory or a new production plant, or even its direct management.
Validation Master Plan for new facility
06
We offer consultancy in assisting the customer in the development of a project that starts from the customer's strategic data (Volumes, Lots, number of Units, etc) and follows the Concept Design through the Basic Design phases up to the Final Detailed Project, for a new process, a new plant, or production department including laboratories. The consultancy extends to the direct management of Project Management
Concept Design and Project Management
07
We have 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.
GMP training
08
