Arcadia and Spectrum Joint Venture Co. Ltd.Arcadia Spectrum is a knowledge based Engineering firm, specializing in providing complete design and engineering solutions to Pharmaceuticals, Food, Beverages, Cosmetics & Personal Care Industry with head office in Bangkok, Thailand.
Arcadia Spectrum provide complete Basic, Detailed Engineering, Procurement Assistance, Project Management Construction Management, Qualification and Validation Services.
Arcadia Spectrum is fully conversant with the cGMP and GLP requirements of international regulatory authorities like USFDA/EU/PIC/s etc. We follow food standards such as HACCP, FSSAI, GFSI, SQF etc.
Azierta, Spain and Spectrum Group Joint VentureCollaboration with AUDINOVA, AZIERTA, Spain to conduct GxP audits and EU authorization in Asian countries.
Azierta your to landing in Europe, Non-EU companies access to the EU pharma market. Strategies to access the European Pharma Market.
- Becoming a MAH through a dossier acquisition – This avenue is recommended for companies seeking to land in Europe quickly through the purchasing of dossiers
- Becoming a MAH through a dossier adaptation – This option is recommended for companies looking to adapt their own dossiers so as to be able to sell their own products in Europe through the adaptation of their manufacturing processes and facilities. In order to comply with European requirements, a bioequivalence study must be presented along with all the adapted documentation
- Becoming a suitable CMO for the EU – This process is ideal for Non-EU Manufacturing Companies that aren't interested in obtaining MAH status, but are looking to maximise the use of their facilities and drive up sales, not only in Europe but also worldwide