Sisthema is able to offer consultancy in different fields of the pharmaceutical, cosmetic and food sectors.

Thanks to highly qualified consultants, we can support the companies with targeted projects or provide your personnel with an adequate training.

Our way of working is totally customer oriented and, for this reason, we usually do preliminary visits to our customers’ headquarters, in order to understand together the needs of the company and the faster and cheaper ways to satisfy them.

See below the list of main consulting activities we are able to offer:

  • Analytical Methods Validation
  • Risk Assessment GMP
  • Elemental Impurities ICH Q3
  • Batch Record Review
  • Periodic Review
  • Data Integrity
  • Quality Review
  • GMP
  • General plan of validation VMP
  • Computer System Validation
  • HACCP
  • ISO 13485
  • Support in writing the SMF
  • Development of the Dossier for MD
  • PMC
  • Documents for the CE labeling of medical devices
  • Microbiology Sterility Assurance
  • Stability: protocols and data processing
  • GMP for Clinical Studies
  • Cleaning and process validation
  • Planning and development of the Quality System
  • Support in preparation of AIFA and FDA inspections
  • PQR
  • ISO 22716
  • Quality Agreement
  • Development of the Registration Dossier of medicinal products
  • Writing of the Technical File
  • Evaluation and review of the Dossier for products already registered
  • Statistics applied to analysis
  • Stability: shipping study
  • Root Guide Investigation
  • CAPA
SISTHEMA SRL
Legal head office: Via U. Visconti Di Modrone 33 - 20122 Milano
Headquarters 1 : Via G. di Vittorio 70 – 20026 Novate Milanese (MI)
Headquarters 2 : Via Don Luigi Sturzo 9 – 20026 Novate Milanese (MI)
Office telephone +39 02 3562759 - E-mail info@sisthema.biz
VAT Number: IT12987810152 - Pec info@pec.sisthema.biz - REA Number: MI1603678 - Assets € 100.000 i.v.