Regulatory Affairs and Quality

We offer custom-tailored Services

Regulatory Affairs

Are you also sometimes short of time or do you have the feeling that time is flying by so quickly that important jobs are left undone? That is where we can help. Our experienced Regulatory Team will be pleased to support you. We can provide solutions tailored to your requirements in the following fields:

 

Marketing Authorisation Application (MAA)

  • NCE: normal process, fast track, orphan drug
  • eCTD
  • Generics
  • Biotechnology products

Marketing Authorisation transfer

  • Legal Representation in Switzerland
  • Qualified Person

Maintenance

  • Type I and Type II variations
  • Renewals

 

Product Information

  • Local product information
  • Patient information
  • Abbreviated product information

Other Regulatory Services

      • GSASA questionnaire
      • Expert reports, overviews, summaries
      • Reimbursement application
      • Pharmacovigilance support
      • Strategic consulting in regulatory matters
      • Support in contacts with health authorities (Swissmedic, BAG)

 

 

 

We support our clients in strategic decisions, regulatory intelligence and services.

 

Contact us now     Contact us for support in Regulatory Affairs

 

 

 

Quality

Swiss-based at home in Europe

We currently provide corporate organisations, their affiliates and Swiss companies with quality services.

  • Set-up and maintenance of quality system
  • Quality surveillance including GLP, GMP, PQR, GDP
  • Management and control of PQRs
  • Drafting of Technical Agreements
  • Pharmacovigilance
  • Promotion
  • Green Light

 

 

Marketing Authorisation Holder

The sister company of Five Office Ltd acts as Marketing Authorisation Holder and hosts product licenses. Support of activities:

  • Sales and distribution in Switzerland
  • Export licenses and management of export activities
  • Foreign trade according to Swiss regulations

 

 

CONTACT US NOW     Contact us for support in Quality

 

 

Contact Details

Five Office Ltd

Guyer-Zeller-Strasse 10

8620 Wetzikon

Switzerland

 

Tel.: +41 44 932 30 32

Email: welcome@five.ch

Future Health Pharma GmbH

Guyer-Zeller-Strasse 10

8620 Wetzikon

Switzerland

 

Tel.: +41 44 932 20 02

Email: welcome@futurehealth.ch