AaMEDI offers for Swiss Pharma companies

GDP Quality Assurance and Regulatory Sevices 

 

AaMEDI 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
- Production of API's
- Wholesale of pharmaceuticals with release
- Wholesale of pharmaceuticals without release
- Import of pharmaceuticals with release 
- Import of pharmaceuticals without release
- Export pharmaceuticals
- Trade abroad
- Broker activities

More info

Swissmedic license
Quality tasks

AaMEDI offers 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

We offer also a Documentation Management System (DMS) for the quality  documentations consisting ot Audit trail, which is needed for GMP, GDP, GLP and other Quality Dokumentation. 


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

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