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:

  • GMP, Good Manufacturing Practices
  • Cleaning & Process Validation
  • Support in preparation of AIFA and FDA inspections
  • Batch Record Review
  • PQR, Quality Review, Root Cause Investigation and CAPA
  • GAP Analysis
  • Elemental Impurities ICH Q3
  • Support in writing the SMF
  • Quality Agreement
  • Risk Management & Risk Assessment GMP
  • Supplier Audit
  • Data Integrity
  • ISO 9001 – ISO 13485 – ISO 22716

Sisthema also works with excellent Partners to:

  • Regulatory Activity for Dossier of Medication Registration and API
  • Toxicology and PDE studies
  • Medical Device registration dossier, Technical File drawing and PMC, Medical Device CE marking
  • Validation of Computerized Systems, ERP, SCADA and Excel sheets

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.