Quality Assurance and Regulatory Sevices 


Quality Assurance Services

Responsible Person RP FvP  

Every Pharma company in Switzerland with Swissmedic licenses must employ a Responsible Person RP (Fachtechnisch verantwortliche Person, FvP).
The RP must follow in his tasks EU-GDP Guidelines as well as all Swissmedic regulations.
The qualification of the RP is defined in AMBV.

RP FvP tasks and responsibilities

- Continuously quality management meetings
- Creating and maintaining EU-GDP Quality system
- Handling of GDP Documentation
- Creating, maintaining, training, releasing and archiving of SOPs
- Creating and signing Technical quality agreements
- Checking commercial agreements
- Creating and maintaining Job descriptions
- GDP transport / temperature releasing
-  Performing Supplier audits and qualifications
- Customer qualifications, Change control
- Swissmedic Inspections, contactperson towards Swissmedic  
- Perform Swissmedic license applications
- Internal and external audits
- Handling of Complaints, Deviations and Return of Goods
- Risk and Recall Management
- Handling of all Wholesale Operations
- CAPA, Falsified medicines
- Management Reviews

Swissmedic License applications

AaMEDI can prepare for you the Swissmedic License applications. Following licenses are available:
- Manufactuting of pharmaceuticals and API's
- Wholesale of pharmaceuticals 
- Import of pharmaceuticals with release 
- Import of pharmaceuticals without release
- Export pharmaceuticals
- Trade abroad
- Broker activities

More info

Swissmedic license
Quality tasks

Quality Management Services

AaMEDI provides following QA services:
- Setup of quality system and implementation
- Maintain the quality system 
- Responsible Person (RP) / FvP
- RP deputy services / FvP Stellvertreter
- Qualified Person (QP) services
- Support in GDP/GVP/GMP - related issues
- Pharmacovigilance Responsibility
- Auditing services, site visits
- Technical Quality Agreements
- Swissmedic License Applications
- Swissmedic issues

Regulatory Services

AaMEDI offers international regulatory services in co-operation with our partners as follows
- Regulatory affairs filing
- Variations
- Submission of files
- Adaptation to the Swiss requirements
- Medical information / leaflets
- Packaging related questions
- Price negotiation for Switzerland

Our Partners have 20 years of experience with international regulatory affairs and with Swissmedic.

Quality triangle

© Copyright 2023 AaMEDI - All Rights Reserved       Created by MITweb